Identity
- Trade Name
- Isolation Gown EUDAMED
- Device Name
- Isolation Gown EUDAMED
- Model / Reference
- L EUDAMEDXXL EUDAMEDM EUDAMEDXL EUDAMEDCustomized EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970542770591 EUDAMED06970542770539 EUDAMED06970542770508 EUDAMED06970542770560 EUDAMED06970542770515 EUDAMED06970542770621 EUDAMED06970542770577 EUDAMED06970542770522 EUDAMED06970542770607 EUDAMED
- Basic UDI-DI
- 697054277IGZF EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I 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
Isolation Gown by Suzhou Suning Underpad Co., Ltd. — 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 | 697054277IGZF | Class I | Active |
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Manufacturer
- Manufacturer
- Suzhou Suning Underpad Co., Ltd.
- EUDAMED SRN
- CN-MF-000020331
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (9)
- EUDAMED c28c92e2-1e2f-4a83-a262-fe859dc05673 61 fields · synced Jul 29, 2026
- EUDAMED c0aa4822-4074-4f66-bcc0-70cf2216a277 61 fields · synced May 16, 2026
- EUDAMED 50609631-89d7-4e24-a457-0b8c3e35f0aa 61 fields · synced May 17, 2026
- EUDAMED 0d072b0c-adca-4921-9103-dc68ee74d2f7 61 fields · synced May 17, 2026
- EUDAMED db4de852-0107-4f70-b763-4d6a7023bf5c 61 fields · synced May 18, 2026
- EUDAMED 29f6626f-c410-4b24-8873-46105c992e91 61 fields · synced May 19, 2026
- EUDAMED 6ea59026-4824-4b51-831c-a8cac8179fa1 61 fields · synced May 19, 2026
- EUDAMED 0108e0b8-e338-4c7f-a29e-2d56e9d3107c 61 fields · synced May 19, 2026
- EUDAMED 477a8cd2-62b6-4737-8244-219fa6cf9b3c 61 fields · synced May 19, 2026