Identity
- Device Name
- Isolation Gowns EUDAMED
- Model / Reference
- s,m,l,xl,xxl,xxxl EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973509181249 EUDAMED
- Basic UDI-DI
- 697350918TD004HC EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 Gowns by Xiantao Tongda Non-Woven 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 | 697350918TD004HC | Class I | Active |
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Manufacturer
- Manufacturer
- Xiantao Tongda Non-woven Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000024554
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED fc4b409f-c6a0-429d-a417-90b07060045f 61 fields · synced Jun 19, 2026
- EUDAMED fc4b409f-c6a0-429d-a417-90b07060045f-1 61 fields · synced Jun 10, 2026