Identity
- Device Name
- Rapidzyme PR EUDAMED
- Model / Reference
- PF-22 EUDAMED6065 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-935681700000022LCGZ EUDAMED
- Basic UDI-DI
- B-935681700000022LCGZ EUDAMED
- EMDN Code
- D0801 ENZYMATIC DETERGENTS FOR MEDICAL DEVICES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Medical device disinfection agent
Rapidzyme PR by Novapharm Research (Australia) Pty Ltd — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-935681700000022LCGZ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Novapharm Research (Australia) Pty Ltd
- EUDAMED SRN
- AU-MF-000016736
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED 95c3ae4a-ea4d-49c9-a17c-7fe27a582841 61 fields · synced Jun 19, 2026