Identity
- Trade Name
- Splint EUDAMED
- Device Name
- Splint EUDAMED
- Model / Reference
- 460mm×110mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06940181416075 EUDAMED
- Basic UDI-DI
- 694018141315DC EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Splint by Zhuozhou Huanuo Life-Saving Equipment 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 | 694018141315DC | Class I | Active |
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Manufacturer
- Manufacturer
- Zhuozhou Huanuo Life-Saving Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000054282
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 1c973783-9380-498f-883c-7289aecc15b2 61 fields · synced Oct 6, 2026