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Coverall - SBPP coated with micro-porous film
EUDAMEDClass I (EU MDR)
Ref Coverall - SBPP coated with micro-porous filmModel Coverall - PE, Coverall - SBPP, Coverall - SBPP Coated, Coverall - SMS, Coverall - SBPP coated with micro-porous film
Identity
- Trade Name
- Coverall - SBPP coated with micro-porous film EUDAMED
- Device Name
- Coverall EUDAMED
- Model / Reference
- Coverall - PE, Coverall - SBPP, Coverall - SBPP Coated, Coverall - SMS, Coverall - SBPP coated with micro-porous film EUDAMEDCoverall - SBPP coated with micro-porous film EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00697549344421 EUDAMED
- Basic UDI-DI
- 697549344COVERALLSBP EUDAMED
- Direct Marketing DI
- 00697549344421 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
Coverall - SBPP coated with micro-porous film by Carestone Medical & Protective Products Co., Ltd. — Class I — MDR — listed in EUDAMED
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 | 697549344COVERALLSBP | Class I | Active |
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Manufacturer
- Manufacturer
- Carestone Medical & Protective Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000027756
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED a05707e3-6b01-4e3a-9c98-dfd2b8976d89 61 fields · synced Oct 6, 2026