← Back to catalogue
Splints
EUDAMEDClass I (EU MDR)
Ref 4.5*9.5CMModel 15*92CM、11*100CM、11*92CM、11*91CM、11*90CM、11*72CM、11*71CM、11*62CM、11*61CM、11*46CM、11*45CM、11*23CM、11*25CM、4.5*9.5CM or customized
Identity
- Device Name
- Splints EUDAMED
- Model / Reference
- 15*92CM、11*100CM、11*92CM、11*91CM、11*90CM、11*72CM、11*71CM、11*62CM、11*61CM、11*46CM、11*45CM、11*23CM、11*25CM、4.5*9.5CM or customized EUDAMED4.5*9.5CM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978729270339 EUDAMED
- Basic UDI-DI
- 697872927SplintsRY EUDAMED
- EMDN Code
- M030505 ZIMMER SPLINTS 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
Splints by Anping County Changtai Medical Equipment Factory — 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 | 697872927SplintsRY | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Anping County Changtai Medical Equipment Factory
- EUDAMED SRN
- CN-MF-000048036
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 11458f39-e0de-451e-9a20-e596e0fc894a 61 fields · synced Jun 18, 2026