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Domus 2+
EUDAMEDClass IIa (EU MDR)
Ref 9P-046520Model 9P-046520Ref 9P-047580
by Wellell Inc.
Identity
- Trade Name
- Domus 2+ EUDAMEDDomus 2 EUDAMED
- Device Name
- Domus 2+ EUDAMEDDomus 2 EUDAMED
- Model / Reference
- 9P-046520 EUDAMED9P-047580 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719893349184 EUDAMED04719893350708 EUDAMED04719893349627 EUDAMED04719893349122 EUDAMED
- Basic UDI-DI
- B-04719893349184 EUDAMEDB-04719893350708 EUDAMEDB-04719893349627 EUDAMEDB-04719893349122 EUDAMED
- EMDN Code
- V080701 ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Domus 2+ 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-04719893349184 | 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 (4)
- EUDAMED 42cf7476-b505-4988-a1f2-08850afe3ac1 61 fields · synced Jul 31, 2026
- EUDAMED 5b0abcea-4e63-4cc4-846d-28b954ce9781 61 fields · synced Jul 15, 2026
- EUDAMED 9110af77-7dde-4241-a450-7640a8a5966e 61 fields · synced Jul 15, 2026
- EUDAMED 3ddbe6ec-a7af-4fc3-bcdb-17c2536393d9 61 fields · synced Jul 31, 2026