Identity
- Trade Name
- BLOUSON DE BLOC OPERATOIRE EUDAMED
- Device Name
- SMS warm jacket, long sleeves EUDAMED
- Model / Reference
- JK-XL EUDAMEDJK-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973122513991 EUDAMED06973122513977 EUDAMED
- Basic UDI-DI
- 697312251JK1008A EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Blouson De Bloc Operatoire 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 | 697312251JK1008A | 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 (2)
- EUDAMED 6a2b872b-21f7-488c-aecd-7a3634cb0907 61 fields · synced Jul 30, 2026
- EUDAMED c14faebf-aa01-48d7-a62b-cb88652da3cb 61 fields · synced May 18, 2026