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Isolation Gown - SMS
EUDAMEDClass I (EU MDR)
Ref Isolation Gown - SMSModel Isolation Gown - SBPP, Isolation Gown - SBPP+PE, Isolation Gown - SMS, Isolation Gown - SBPP coated with micro-porous film
Identity
- Trade Name
- Isolation Gown - SMS EUDAMED
- Device Name
- Isolation Gown EUDAMED
- Model / Reference
- Isolation Gown - SBPP, Isolation Gown - SBPP+PE, Isolation Gown - SMS, Isolation Gown - SBPP coated with micro-porous film EUDAMEDIsolation Gown - SMS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00697549344162 EUDAMED
- Basic UDI-DI
- 697549344ISOLATIONGOWNS6R EUDAMED
- Direct Marketing DI
- 00697549344162 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
Isolation Gown - SMS by Carestone Medical & Protective Products 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 | 697549344ISOLATIONGOWNS6R | 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 ea5f25e8-71bb-4b24-992f-c0f449607ac9 61 fields · synced Oct 5, 2026