← Back to catalogue
PentaPure KONZ
EUDAMEDClass I (EU MDR)
Ref Pura530/2145951Model 578
by PRISMAN GmbH
Identity
- Trade Name
- PentaPure KONZ EUDAMED
- Device Name
- LavaPure SB Konz. EUDAMED
- Model / Reference
- 578 EUDAMEDPura530/2145951 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04064797003602 EUDAMED
- Basic UDI-DI
- ++EPRM578EW EUDAMED
- EMDN Code
- D0899 DETERGENTS FOR MEDICAL DEVICES - OTHER 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
PentaPure KONZ 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 | ++EPRM578EW | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PRISMAN GmbH
- EUDAMED SRN
- DE-MF-000009900
Sources (1)
- EUDAMED 4c42da5e-9d0e-4183-9be7-9a84819a3201 61 fields · synced Jun 19, 2026