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Splints
EUDAMEDClass I (EU MDR)
Ref 11*46CMModel 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 EUDAMED11*46CM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978729270292 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 |
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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 224751b1-9849-48ff-9ba9-d31d5e95b1e1 61 fields · synced Jun 19, 2026