Identity
- Trade Name
- Non-woven Isolation Gown EUDAMED
- Device Name
- Non-woven Isolation Gown EUDAMED
- Model / Reference
- C-FHF-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972907840284 EUDAMED
- Basic UDI-DI
- 697290784NIGVR 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
Non-woven Isolation Gown by Nantong Jianan Medical Products 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 | 697290784NIGVR | Class I | Active |
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Manufacturer
- Manufacturer
- Nantong Jianan Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000039163
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED a8446b39-16df-44ef-8923-1b3bee63799b 61 fields · synced Oct 6, 2026