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Pro-care Auto Bariatric
EUDAMEDClass IIa (EU MDR)
Ref 9P-087520
by Wellell Inc.
Identity
- Trade Name
- Pro-care Auto Bariatric EUDAMED
- Device Name
- Pro-care Auto Bariatric EUDAMED
- Model / Reference
- 9P-087520 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719893348668 EUDAMED
- Basic UDI-DI
- B-04719893348668 EUDAMED
- EMDN Code
- V080701 ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Pro-care Auto Bariatric by Wellell Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04719893348668 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Wellell Inc.
- EUDAMED SRN
- TW-MF-000009159
- Authorised Representative
- Wellell Iberia S.L. ES-AR-000003668
Sources (1)
- EUDAMED fbdd2cb0-d343-419e-8520-4d19c6be036a 61 fields · synced Jul 19, 2026