Identity
- Trade Name
- Domus 1 G2 EUDAMEDDomus 1 EUDAMED
- Device Name
- Alternating Pressure Redistribution System EUDAMEDDomus 1 EUDAMED
- Model / Reference
- 9P-047400 EUDAMED9P-047580 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719893355369 EUDAMED04719893349092 EUDAMED04719893356151 EUDAMED
- Basic UDI-DI
- 302500pmattressI039F EUDAMEDB-04719893349092 EUDAMED
- EMDN Code
- V080701 ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass 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
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
Domus 1 G2 by Wellell Inc. — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 302500pmattressI039F | Class I | Active |
| EUDAMED | European Union | CE/MDR | 302500pmattressI039F | Class I | Active |
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Manufacturer
- Manufacturer
- Wellell Inc.
- EUDAMED SRN
- TW-MF-000009159
- Authorised Representative
- Wellell Iberia S.L. ES-AR-000003668
Sources (3)
- EUDAMED 2393a061-fe5d-4f18-9cea-630a50484207 61 fields · synced Sep 18, 2026
- EUDAMED ae1531ea-4628-422e-8d31-d72a67998ae4 61 fields · synced May 18, 2026
- EUDAMED 34b6a14b-da2a-4f84-9aca-c74fb9072f0f 61 fields · synced Sep 18, 2026