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Bubble Cushion
EUDAMEDClass I (EU MDR)
Ref NHI-BC-001Model NHI-BC-001,NHI-BC-002,NHI-BC-003,NHI-BC-004
Identity
- Device Name
- Bubble Cushion EUDAMED
- Model / Reference
- NHI-BC-001,NHI-BC-002,NHI-BC-003,NHI-BC-004 EUDAMEDNHI-BC-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08994468810023 EUDAMED
- Basic UDI-DI
- 899446881BC001LE EUDAMED
- EMDN Code
- V080702 NON ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES 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
Bubble Cushion 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 | 899446881BC001LE | 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 b20c386f-0f96-4c83-8970-f930037033da 61 fields · synced Jun 19, 2026