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Splints
EUDAMEDClass I (EU MDR)
Ref 15*92CMModel 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 Ref 11*71CMRef 11*90CMRef 11*23CMRef 11*61CMRef 11*45CM
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 EUDAMED15*92CM EUDAMED11*71CM EUDAMED11*90CM EUDAMED11*23CM EUDAMED11*61CM EUDAMED11*45CM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978729270209 EUDAMED06978729270261 EUDAMED06978729270247 EUDAMED06978729270315 EUDAMED06978729270285 EUDAMED06978729270308 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 (6)
- EUDAMED fb8ee279-d04c-42e2-bb5d-879ff82802ff 61 fields · synced Aug 1, 2026
- EUDAMED 570fad3c-78db-4cd3-99b3-90a46e98f3d9 61 fields · synced Jun 20, 2026
- EUDAMED 247e39c5-4075-49a6-8eb0-8da81a1426dd 61 fields · synced Jul 14, 2026
- EUDAMED dd4b9c47-1175-4a2d-91fc-26d9f151e068 61 fields · synced Jul 18, 2026
- EUDAMED 962fed66-93d0-401a-a01e-f3960277cb2c 61 fields · synced Jul 22, 2026
- EUDAMED fb38aee0-9757-4452-a3f1-5edcb715b490 61 fields · synced Aug 1, 2026