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Fartuch medyczny SMS
EUDAMEDClass I (EU MDR)
Ref EM-CR-0003-SMS-40-B-MRef EM-CR-0003-SMS-40-B-XXLRef EM-CR-0003-SMS-40-B-L
Identity
- Trade Name
- Fartuch medyczny SMS EUDAMED
- Device Name
- isolation gown EUDAMED
- Model / Reference
- EM-CR-0003-SMS-40-B-M EUDAMEDEM-CR-0003-SMS-40-B-XXL EUDAMEDEM-CR-0003-SMS-40-B-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973122515162 EUDAMED06973122515223 EUDAMED06973122515186 EUDAMED
- Basic UDI-DI
- 697312251IG10073 EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Fartuch medyczny SMS by Crown Name Disposable Hygiene Products Fty. 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 | 697312251IG10073 | Class I | Active |
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Manufacturer
- Manufacturer
- Crown Name Disposable Hygiene Products Fty. Ltd.
- EUDAMED SRN
- CN-MF-000008238
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED d599fe2a-c831-4b73-98c5-90d69cd696a0 61 fields · synced Oct 6, 2026
- EUDAMED c3cce4d4-a4a2-4bf2-9b2a-77bb15b4defd 61 fields · synced May 18, 2026
- EUDAMED ee2b5d61-07e4-47e7-a1a0-248bc04640f0 61 fields · synced May 19, 2026