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Protective gowns,
EUDAMEDClass I (EU MDR)
Ref TM0304-LModel TM0304Ref TM0304-XLRef TM0304-XXL
Identity
- Trade Name
- Protective gowns, EUDAMEDProtective gowns EUDAMED
- Device Name
- SMS isolation gown EUDAMED
- Model / Reference
- TM0304 EUDAMEDTM0304-L EUDAMEDTM0304-XL EUDAMEDTM0304-XXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974618410084 EUDAMED06974618410091 EUDAMED06974618410107 EUDAMED
- Basic UDI-DI
- 697461841TM0304JA EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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 gowns, 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 | 697461841TM0304JA | 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 (3)
- EUDAMED 4f5fbca0-9e08-4922-8515-df55e66e5e72 61 fields · synced Jul 26, 2026
- EUDAMED 3de8f47b-af93-47db-acd8-013db0863c89 61 fields · synced May 18, 2026
- EUDAMED 619274e3-eb63-4e33-b7f5-3d089bfde83a 61 fields · synced May 18, 2026