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Splint - EUDAMED Registration 06977728545509

Access comprehensive regulatory information for Splint 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 06977728545509 and manufactured by Suzhou Ireland Medical Equipment Co., Ltd. in China.

This page provides complete registration details including trade name (Splint), manufacturer information, authorized representative details, competent authority (DE/CA304 - Marktüberwachung Medizinprodukte Bayern), 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
06977728545509
No
Splint
Trade Name: Splint
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Device Description (EMDN)

BANDAGES AND SPLINTS - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
M03050299
Trade Name
Splint
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06977728545509
Basic UDI
697772854DWSPXE
Version Date
September 25, 2024
Manufacturer Last Update
September 12, 2024
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
Building E, Liangfeng Machinery Park, No.3 Zhenxing Road, Yangshe Town Zhangjiagang City
Email
provider@dragon-iec.com
Authorized Representative
SRN
DE-AR-000000087
Country
Germany
Address
8 Mies-van-der-Rohe-Strasse Munich
Email
info@medpath.pro
Telephone
+49 (0) 89 8130 6837
Regulatory Information
Competent Authority
DE/CA304 - Marktüberwachung Medizinprodukte Bayern
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Device Characteristics
Human Tissues
No
Animal Tissues
No