Identity
- Trade Name
- BROMELINE PK EUDAMED
- Device Name
- ENZYMES (E.G. BROMELIN / PAPAIN, ETC.) EUDAMED
- Model / Reference
- B10351 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 23661562103519 EUDAMED
- Basic UDI-DI
- 3661562ABROMELINEXXXXXXQS EUDAMED
- EMDN Code
- W0103030307 ENZYMES (E.G. BROMELIN / PAPAIN, ETC.) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
Bromeline Pk by Diagast — 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 | 3661562ABROMELINEXXXXXXQS | Class A | Active |
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Manufacturer
- Manufacturer
- Diagast
- EUDAMED SRN
- FR-MF-000012310
Sources (1)
- EUDAMED acff3fce-516d-4102-b795-224e3eda79ba 61 fields · synced Jun 19, 2026