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Foam Wedges
EUDAMEDClass I (EU MDR)
Ref NHI-FW-001Model NHI-FW-001,NHI-FW-002,NHI-FW-003,NHI-FW-004
Identity
- Device Name
- Foam Wedges EUDAMED
- Model / Reference
- NHI-FW-001,NHI-FW-002,NHI-FW-003,NHI-FW-004 EUDAMEDNHI-FW-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08994468810030 EUDAMED
- Basic UDI-DI
- 899446881FW001S6 EUDAMED
- EMDN Code
- V08068099 MEDICAL BEDS - OTHER ACCESSORIES 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
Foam Wedges by Pt Newlife Healthcare International — 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 | 899446881FW001S6 | Class I | Active |
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Manufacturer
- Manufacturer
- Pt Newlife Healthcare International
- EUDAMED SRN
- ID-MF-000051541
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 4db5005b-3ba4-4a4d-87b9-7d52543ac3a3 61 fields · synced Jun 18, 2026