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Bouffant Caps
EUDAMEDClass I (EU MDR)
Ref 04010-B-MModel TM01Ref 04010-W-MRef 04010-G-XLRef 04010-B-XL
Identity
- Trade Name
- Bouffant Caps EUDAMED
- Device Name
- Caps EUDAMED
- Model / Reference
- TM01 EUDAMED04010-B-M EUDAMED04010-W-M EUDAMED04010-G-XL EUDAMED04010-B-XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974618410503 EUDAMED06974618410480 EUDAMED06974618410534 EUDAMED06974618410510 EUDAMED
- Basic UDI-DI
- 697461841TM01NT EUDAMED
- EMDN Code
- T0207 CAPS AND HEADWEAR (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
Bouffant Caps 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 | 697461841TM01NT | 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 (4)
- EUDAMED 3c369d6a-59b4-48ce-8f6e-45fe9573708d 61 fields · synced Oct 5, 2026
- EUDAMED 5667c344-fa72-4a46-964c-c9ac34cd3e1b 61 fields · synced May 17, 2026
- EUDAMED f22b94cc-0d50-4720-bc2b-708d66e0edb4 61 fields · synced May 18, 2026
- EUDAMED 78347a79-949f-45ca-8c9a-f0d9c688d7c4 61 fields · synced May 18, 2026