Identity
- Trade Name
- Protective gown EUDAMED
- Device Name
- PP isolation gown EUDAMED
- Model / Reference
- TM0301 EUDAMED5016 EUDAMED5015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974618410909 EUDAMED06974618410398 EUDAMED
- Basic UDI-DI
- 697461841TM0301J4 EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMEDT0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
Protective gown by Ningbo Transo-Medical 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 | 697461841TM0301J4 | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Transo-Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000009687
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (2)
- EUDAMED e9c3076c-db4c-46e2-ae4e-30a83f9d3a6c 61 fields · synced Jul 17, 2026
- EUDAMED 41be391d-878c-4c5f-9b28-15539626b672 61 fields · synced May 19, 2026