Identity
- Trade Name
- Bromelase 30 EUDAMED
- Device Name
- Bromelase 30 EUDAMED
- Model / Reference
- Bromelase 30 EUDAMED213578 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640137340681 EUDAMED
- Basic UDI-DI
- 764013734Bromelase305Z EUDAMED
- Direct Marketing DI
- 07640137340681 EUDAMED
- EMDN Code
- W0103030307 ENZYMES (E.G. BROMELIN / PAPAIN, ETC.) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Bromelase 30 by Medion Grifols Diagnostics Ag — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 764013734Bromelase305Z | Class A | Active |
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Manufacturer
- Manufacturer
- Medion Grifols Diagnostics AG
- EUDAMED SRN
- CH-MF-000024272
- Authorised Representative
- Diagnostic Grifols, S.A. ES-AR-000001573
Sources (2)
- EUDAMED 7caed8c1-e313-4c60-b425-549de722c511 61 fields · synced Jun 18, 2026
- EUDAMED 443c7e3d-2cbf-4d5c-a01b-ef237567759e 61 fields · synced Jun 18, 2026