Identity
- Trade Name
- Upper limbs brace Class EUDAMED
- Device Name
- Upper limbs brace Class EUDAMED
- Model / Reference
- GS3251 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974221790504 EUDAMED
- Basic UDI-DI
- 697422179GS3251DV EUDAMED
- Direct Marketing DI
- 06974221790504 EUDAMED
- EMDN Code
- Y090312 GLOVES AND HANDLES FOR PROSTHESES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Upper limbs brace Class by Hengshui Gangsheng Medical Instruments Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697422179GS3251DV | Class I | Active |
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Manufacturer
- Manufacturer
- Hengshui Gangsheng Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000011445
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED cb3750f0-b93e-40c5-8779-c5aac7067614 61 fields · synced Oct 6, 2026