EUDAMED registration 06973105230365NoSplint
Anping Guardian Medical Equipment Co., LtdClass IEU EUDAMED
VerifiedEUDAMED · official EU database
Device classification
- Risk class
- Class I
- CND nomenclatures code
- M03050299
- Implantable
- No
- Reusable
- No
- Measuring function
- No
Registration information
- Primary DI
- 06973105230365
- Basic UDI
- 697310523SPLINTPK
- Version date
- December 09, 2024
- Manufacturer last update
- October 25, 2021
- Active status
- No
Manufacturer
- Manufacturer name
- Anping Guardian Medical Equipment Co., Ltd
- Country
- China
- Country type
- NON_EU
- Address
- Nan Sucun 500 meters Hengshui City,Hebei Province
- info@splint.cn
Authorized representative
- SRN
- DE-AR-000000002
- Country
- Germany
- Address
- 10 Borkstrasse Münster
- ecrep@medneteurope.com
- Telephone
- +49 251 322 66 64
Regulatory information
- Competent authority
- DE/CA22 - Bezirksregierung Münster
- Applicable legislation
- MDR (REGULATION (EU) 2017/745 on medical devices)
- Placed on the market
- Germany
Device characteristics
- Human tissues
- No
- Animal tissues
- No
Device description (EMDN)
BANDAGES AND SPLINTS - OTHER
About this record
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 06973105230365 and manufactured by Anping Guardian Medical Equipment Co., Ltd in China.
This page provides complete registration details including manufacturer information, authorized representative details, competent authority (DE/CA22 - Bezirksregierung Münster), 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.