Identity
- Trade Name
- Coverall without hood EUDAMED
- Device Name
- Coverall with stand-up collar EUDAMED
- Model / Reference
- TM0602 EUDAMED7040 EUDAMED7050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974618410473 EUDAMED06974618410459 EUDAMED
- Basic UDI-DI
- 697461841TM0602JM EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER 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
Coverall without hood 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 | 697461841TM0602JM | 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 4b545cfa-0bd8-4b96-b5b5-f987f99570c5 61 fields · synced Jul 30, 2026
- EUDAMED db9fbf09-23c6-4f11-adc9-6faba19048b5 61 fields · synced May 19, 2026