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fhs profylaxepastazirco
EUDAMEDClass I (EU MDR)
Ref 161351Model 446
by PRISMAN GmbH
Identity
- Trade Name
- fhs profylaxepastazirco EUDAMED
- Device Name
- Prophylaxepaste ZIRCO EUDAMED
- Model / Reference
- 446 EUDAMED161351 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04064797009871 EUDAMED
- Basic UDI-DI
- ++EPRM446EC EUDAMED
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
fhs profylaxepastazirco by PRISMAN GmbH — 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 | ++EPRM446EC | Class I | Active |
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Manufacturer
- Manufacturer
- PRISMAN GmbH
- EUDAMED SRN
- DE-MF-000009900
Sources (1)
- EUDAMED ab3db45c-adfd-4e31-b6d4-5f4f96496194 61 fields · synced Jun 19, 2026