Identity
- Trade Name
- Koszula pacjenta EUDAMED
- Device Name
- Patient Apparel EUDAMED
- Model / Reference
- EM-CR-0024-SMS-U-B-ML EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973122515421 EUDAMED
- Basic UDI-DI
- 697312251PA2008B 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
Koszula pacjenta 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 | 697312251PA2008B | 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 (1)
- EUDAMED 62f74654-4319-46f0-b452-41f7a9093396 61 fields · synced Jun 19, 2026