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Upper Limb Brace
EUDAMEDClass I (EU MDR)
Ref C306Model 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 EUDAMEDC306 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974286371526 EUDAMED
- Basic UDI-DI
- 697428637ULB01QS EUDAMED
- EMDN Code
- Y060613 WRIST-HAND-FINGERS ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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 |
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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 3382928f-bc60-48c4-adb0-87e9c93e6230 61 fields · synced Jun 19, 2026