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OPHTHALMIC FORCEPS - EUDAMED Registration 06974957360705

Access comprehensive regulatory information for OPHTHALMIC FORCEPS in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 06974957360705 and manufactured by GAUSH PRECISION LTD in China.

This page provides complete registration details including trade name (OPHTHALMIC FORCEPS(chalazion forceps)), manufacturer information, authorized representative details, competent authority (Agencia Espaรฑola de Medicamentos y Productos Sanitarios), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.

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EUDAMED Official Data
Class I
06974957360705
No
OPHTHALMIC FORCEPS
Trade Name: OPHTHALMIC FORCEPS(chalazion forceps)
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Device Description (EMDN)

OPHTHALMIC SURGERY FORCEPS, SINGLE-USE

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Q021102
Trade Name
OPHTHALMIC FORCEPS(chalazion forceps)
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06974957360705
Basic UDI
697495736ED001K9
Version Date
February 21, 2025
Manufacturer Last Update
December 25, 2024
Active Status
No
Manufacturer
Manufacturer Name
GAUSH PRECISION LTD
Country
China
Country Type
NON_EU
Address
Room 201,Building 8,No.188 Fuchunjiang Road,HuQiu District Suzhou City
Email
szra@gaush.com
Authorized Representative
SRN
ES-AR-000001202
Country
Spain
Address
55 Calle de Almansa Madrid
Email
leis@riomavix.com
Regulatory Information
Competent Authority
Agencia Espaรฑola de Medicamentos y Productos Sanitarios
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Device Characteristics
Human Tissues
No
Animal Tissues
No