Identity
- Trade Name
- Oral Care Gąbka z odsysaniem EUDAMED
- Device Name
- Oral Care Gąbka z odsysaniem EUDAMED
- Model / Reference
- 10003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 59037193133778 EUDAMED
- Basic UDI-DI
- 590371932A0321002LC EUDAMED
- EMDN Code
- Q019003 DENTAL FLOSS AND OTHER DEVICES FOR ORAL HYGIENE (FOR PROFESSIONAL USE) EUDAMED
Classification
- Device Class
- Class IIa 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
Oral Care Gąbka z odsysaniem by Sinmed Spółka Z Ograniczoną Odpowiedzialnością — Class IIa — 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 | 590371932A0321002LC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sinmed Spółka Z Ograniczoną Odpowiedzialnością
- EUDAMED SRN
- PL-MF-000002789
Sources (1)
- EUDAMED fc185cef-e5e0-4a33-87d3-dbd1576d8b27 61 fields · synced Jun 20, 2026