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Domus Auto
EUDAMEDClass IIa (EU MDR)
Ref 9P-077520Model Domus Auto
by Wellell Inc.
Identity
- Trade Name
- Domus Auto EUDAMED
- Device Name
- Domus Auto EUDAMED9P-077520 EUDAMED
- Model / Reference
- 9P-077520 EUDAMEDDomus Auto EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719893350098 EUDAMED04719893350128 EUDAMED04719893312614 EUDAMED04719893348439 EUDAMED04719893353747 EUDAMED04719893353099 EUDAMED04719893349351 EUDAMED04713025009427 EUDAMED04719893354447 EUDAMED04719893351002 EUDAMED04719893350302 EUDAMED04719893345261 EUDAMED
- Basic UDI-DI
- B-04719893350098 EUDAMEDB-04719893350128 EUDAMEDB-04719893312614 EUDAMEDB-04719893348439 EUDAMEDB-04719893353747 EUDAMEDB-04719893353099 EUDAMEDB-04719893349351 EUDAMEDB-04713025009427 EUDAMEDB-04719893354447 EUDAMEDB-04719893351002 EUDAMEDB-04719893350302 EUDAMEDB-04719893345261 EUDAMED
- EMDN Code
- V080701 ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMEDFrance EUDAMEDFinland EUDAMEDSpain 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 Auto 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-04719893350098 | 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 (12)
- EUDAMED 22ceb068-cd18-4a5f-9353-bcd5911200a9 61 fields · synced Jul 31, 2026
- EUDAMED 5cb649b4-82fe-4d53-a1f9-f6777ce52bc7 61 fields · synced Jul 9, 2026
- EUDAMED fbe9fc65-7bb1-467c-a70b-3d119612b4dc 61 fields · synced Jul 9, 2026
- EUDAMED a4014777-0bb8-4352-bd6b-7e6c89d0d4aa 61 fields · synced Jul 11, 2026
- EUDAMED 3f5e80ec-1385-448a-bfa2-cb68c7e7b71e 61 fields · synced Jul 13, 2026
- EUDAMED 80f390ac-57d2-49bd-9f5a-4277fb298431 61 fields · synced Jul 14, 2026
- EUDAMED c6c3b817-2bce-4edb-a20e-1e326b8dca64 61 fields · synced Jul 20, 2026
- EUDAMED bf462e50-5c78-451e-800a-32dfb8c86212 61 fields · synced Jul 25, 2026
- EUDAMED 7d2b2e72-165c-4f35-a638-935b1b87cb2d 61 fields · synced Jul 25, 2026
- EUDAMED 59504e72-b3e4-4e81-90e5-7c0b590fc6d5 61 fields · synced Jul 27, 2026
- EUDAMED ac70b47a-914e-484d-815b-8e9717992199 61 fields · synced Jul 30, 2026
- EUDAMED f03c510a-16a5-4f91-b215-9c538cf4765c 61 fields · synced Jul 31, 2026