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WIDEX WIDEX EVOKE Hearing Aids - HSA Registration DE0504640

Access comprehensive regulatory information for WIDEX WIDEX EVOKE Hearing Aids in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504640 and owned by Widex A/S. The device was registered on June 29, 2020.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0504640
WIDEX WIDEX EVOKE Hearing Aids
HSA Registration Number: DE0504640
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Product Description

The hearing aids are intended as air conduction amplification devices to be used in everyday listening environments. The hearing aids may be equipped with the Zen program intended to provide a relaxing sound background (i.e. music/noise source) for adults who desire to listen to such a background in quiet. The ERBO hearing aid models are indicated for individuals older than 36 months with a range of hearing loss from slight (16 dB HL) to moderately severe (up to 85 dB HL) and all hearing loss configurations. The EBBD3 hearing aid models are indicated for individuals with a range of hearing loss from minimal (10 dB HL) to severe-to-profound (105 dB HL) and all hearing loss configurations. The ERB2D hearing aid models are indicated for individuals older than 36 months with a range of hearing loss from minimal (10 dB HL) to severe-to-profound (100 dB HL) and all hearing loss configurations.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration Information
Registration Number
DE0504640
Registration Date
June 29, 2020
Retention Due Date
June 28, 2025
Product Owner
Short Name
Widex A/S
Address
Nymoellevej 6, 3540 Lynge, Denmark, DENMARK
Registrant
Address
2 SHENTON WAY, SGX CENTRE I, #18-01, SINGAPORE 068804
Importer
Address
18 TAI SENG STREET, 18 TAI SENG, #08-08, SINGAPORE 539775 2 SHENTON WAY, SGX CENTRE I, #18-01, SINGAPORE 068804 18 TAI SENG STREET, 18 TAI SENG, #08-08, SINGAPORE 539775
Model Information
Model Name(s)
WIDEX EVOKE App 1.5.1 (iOS) WIDEX EVOKE App 1.5.1 (Android) WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERB0 BTE 110 DEMO WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERB0 BTE 220 DEMO WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERB0 BTE 330 DEMO WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERB0 BTE 440 DEMO WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE ERBO BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE 110 DEMO WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE 220 DEMO WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE 330 DEMO WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE 440 DEMO WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE EBB3D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE 110 DEMO WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE 220 DEMO WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE 330 DEMO WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE WIDEX EVOKE ERB2D BTE 440 DEMO WIDEX COMPASS GPS
Model Identifier(s)
5 300 0014 5 300 0015 8 400 0200 068 8 400 0200 069 8 400 0200 071 8 400 0200 075 8 400 0200 076 8 400 0200 077 8 400 0200 078 8 400 0200 081 8 400 0200 118 8 400 0200 119 8 400 0200 121 8 400 0200 123 8 400 0200 136 8 400 0210 068 8 400 0210 069 8 400 0210 071 8 400 0210 075 8 400 0210 076 8 400 0210 077 8 400 0210 078 8 400 0210 081 8 400 0210 118 8 400 0210 119 8 400 0210 121 8 400 0210 123 8 400 0210 136 8 400 0213 8 400 0220 068 8 400 0220 069 8 400 0220 071 8 400 0220 075 8 400 0220 076 8 400 0220 077 8 400 0220 078 8 400 0220 081 8 400 0220 118 8 400 0220 119 8 400 0220 121 8 400 0220 123 8 400 0220 136 8 400 0223 8 400 0230 068 8 400 0230 069 8 400 0230 071 8 400 0230 075 8 400 0230 076 8 400 0230 077 8 400 0230 078 8 400 0230 081 8 400 0230 118 8 400 0230 119 8 400 0230 121 8 400 0230 123 8 400 0230 136 8 400 0233 8 400 0240 068 8 400 0240 069 8 400 0240 071 8 400 0240 075 8 400 0240 076 8 400 0240 077 8 400 0240 078 8 400 0240 081 8 400 0240 118 8 400 0240 119 8 400 0240 121 8 400 0240 123 8 400 0240 136 8 400 0243 8 400 0250 068 8 400 0250 069 8 400 0250 071 8 400 0250 075 8 400 0250 076 8 400 0250 077 8 400 0250 078 8 400 0250 081 8 400 0250 118 8 400 0250 119 8 400 0250 121 8 400 0250 123 8 400 0250 136 8 402 0200 068 8 402 0200 069 8 402 0200 071 8 402 0200 075 8 402 0200 076 8 402 0200 077 8 402 0200 078 8 402 0200 081 8 402 0200 118 8 402 0200 119 8 402 0200 121 8 402 0200 123 8 402 0200 136 8 402 0210 068 8 402 0210 069 8 402 0210 071 8 402 0210 075 8 402 0210 076 8 402 0210 077 8 402 0210 078 8 402 0210 081 8 402 0210 118 8 402 0210 119 8 402 0210 121 8 402 0210 123 8 402 0210 136 8 402 0211 8 402 0220 068 8 402 0220 069 8 402 0220 071 8 402 0220 075 8 402 0220 076 8 402 0220 077 8 402 0220 078 8 402 0220 081 8 402 0220 118 8 402 0220 119 8 402 0220 121 8 402 0220 123 8 402 0220 136 8 402 0221 8 402 0230 068 8 402 0230 069 8 402 0230 071 8 402 0230 075 8 402 0230 076 8 402 0230 077 8 402 0230 078 8 402 0230 081 8 402 0230 118 8 402 0230 119 8 402 0230 121 8 402 0230 123 8 402 0230 136 8 402 0231 8 402 0240 068 8 402 0240 069 8 402 0240 071 8 402 0240 075 8 402 0240 076 8 402 0240 077 8 402 0240 078 8 402 0240 081 8 402 0240 118 8 402 0240 119 8 402 0240 121 8 402 0240 123 8 402 0240 136 8 402 0241 8 402 0250 068 8 402 0250 069 8 402 0250 071 8 402 0250 075 8 402 0250 076 8 402 0250 077 8 402 0250 078 8 402 0250 081 8 402 0250 118 8 402 0250 119 8 402 0250 121 8 402 0250 123 8 402 0250 136 8 402 0260 068 8 402 0260 069 8 402 0260 071 8 402 0260 075 8 402 0260 076 8 402 0260 077 8 402 0260 078 8 402 0260 081 8 402 0260 118 8 402 0260 119 8 402 0260 121 8 402 0260 123 8 402 0260 136 8 403 0600 068 8 403 0600 069 8 403 0600 071 8 403 0600 075 8 403 0600 076 8 403 0600 077 8 403 0600 078 8 403 0600 081 8 403 0600 118 8 403 0600 119 8 403 0600 121 8 403 0600 123 8 403 0600 136 8 403 0610 068 8 403 0610 069 8 403 0610 071 8 403 0610 075 8 403 0610 076 8 403 0610 077 8 403 0610 078 8 403 0610 081 8 403 0610 118 8 403 0610 119 8 403 0610 121 8 403 0610 123 8 403 0610 136 8 403 0611 8 403 0620 068 8 403 0620 069 8 403 0620 071 8 403 0620 075 8 403 0620 076 8 403 0620 077 8 403 0620 078 8 403 0620 081 8 403 0620 118 8 403 0620 119 8 403 0620 121 8 403 0620 123 8 403 0620 136 8 403 0621 8 403 0630 068 8 403 0630 069 8 403 0630 071 8 403 0630 075 8 403 0630 076 8 403 0630 077 8 403 0630 078 8 403 0630 081 8 403 0630 118 8 403 0630 119 8 403 0630 121 8 403 0630 123 8 403 0630 136 8 403 0631 8 403 0640 068 8 403 0640 069 8 403 0640 071 8 403 0640 075 8 403 0640 076 8 403 0640 077 8 403 0640 078 8 403 0640 081 8 403 0640 118 8 403 0640 119 8 403 0640 121 8 403 0640 123 8 403 0640 136 8 403 0641 COMPASS GPS