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Hybrid Night Splint, Large - X-Large
EUDAMEDClass I (EU MDR)
Ref 30016Model Hybrid Night Splint
Identity
- Trade Name
- Hybrid Night Splint, Large - X-Large EUDAMED
- Device Name
- Night Splint Devices EUDAMED
- Model / Reference
- Hybrid Night Splint EUDAMED30016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810047430445 EUDAMED
- Basic UDI-DI
- 081004743CZT EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES 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
Category: Ankle/foot orthosis
Hybrid Night Splint, Large - X-Large by Ovation Medical — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 081004743CZT | Class I | Active |
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Manufacturer
- Manufacturer
- Ovation Medical
- EUDAMED SRN
- US-MF-000051616
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 408cc642-8d7e-4f92-88a5-9f8c029a1075 61 fields · synced Jun 18, 2026