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Bluza medyczna
EUDAMEDClass I (EU MDR)
Ref EM-CR-0023-PPU-U-B-SRef EM-CR-0023-PPU-U-B-MRef EM-CR-0023-PPU-U-B-XXL
Identity
- Trade Name
- Bluza medyczna EUDAMED
- Device Name
- SMS warm jacket, long sleeves EUDAMEDJacket EUDAMED
- Model / Reference
- EM-CR-0023-PPU-U-B-S EUDAMEDEM-CR-0023-PPU-U-B-M EUDAMEDEM-CR-0023-PPU-U-B-XXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973122515247 EUDAMED06973122515261 EUDAMED06973122515322 EUDAMED
- Basic UDI-DI
- 697312251JK1008A EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER 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
Bluza medyczna 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 (3)
- EUDAMED 1b7e51b6-1e5a-400f-9b47-3965a5f73fb4 61 fields · synced Oct 7, 2026
- EUDAMED 8b29466f-191d-4d9d-9917-0f3fe0c3911b 61 fields · synced May 19, 2026
- EUDAMED 415a9f10-2e68-4913-a14e-0cfc957d4e61 61 fields · synced May 19, 2026