← Back to catalogue
Upper Limb Brace
EUDAMEDClass I (EU MDR)
Ref B301-8Model B101-1 B101-2 B101-3 B102-1 B102-2 B102-3 B102-4 B103-1 B103-2 B103-3 B103-4 B103-5 B104-1 B104-2 B104-3 B104-4 B104-5 B201-1 B201-2 B201-3 B201-4 B201-5 B201-6 B201-7 B202-1 B202-2 B202-3 B202-4 B203-1 B203-2 B203-3 B203-4 B203-5 B203-6 B203-7 B301-1 etc
Identity
- Device Name
- Upper Limb Brace EUDAMED
- Model / Reference
- B101-1 B101-2 B101-3 B102-1 B102-2 B102-3 B102-4 B103-1 B103-2 B103-3 B103-4 B103-5 B104-1 B104-2 B104-3 B104-4 B104-5 B201-1 B201-2 B201-3 B201-4 B201-5 B201-6 B201-7 B202-1 B202-2 B202-3 B202-4 B203-1 B203-2 B203-3 B203-4 B203-5 B203-6 B203-7 B301-1 etc EUDAMEDB301-8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974286371342 EUDAMED
- Basic UDI-DI
- 697428637ULB01QS EUDAMED
- EMDN Code
- Y060609 WRIST (FOREARM) ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Upper Limb Brace by Anping Yikang Medical Instrument 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 | 697428637ULB01QS | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Anping Yikang Medical Instrument Co., Ltd
- EUDAMED SRN
- CN-MF-000045899
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 1ad607de-5120-44af-9f8c-3445b69c241f 61 fields · synced Jun 19, 2026