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Giemsa Pappenheim
EUDAMEDClass A (EU MDR)
Ref 05-12005/LRef 05-M12005Ref 05-12005E
Identity
- Trade Name
- Giemsa Pappenheim EUDAMED
- Device Name
- Staining for histology EUDAMED
- Model / Reference
- 05-12005/L EUDAMED05-M12005 EUDAMED05-12005E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033976232641 EUDAMED08033976234881 EUDAMED08033976232658 EUDAMED
- Basic UDI-DI
- 080339762W0103010301AJ EUDAMED
- Direct Marketing DI
- 08033976232641 EUDAMED08033976234881 EUDAMED08033976232658 EUDAMED
- EMDN Code
- W0103010301 HISTO / CYTO STAINS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Giemsa Pappenheim by Bio-Optica Milano S.p.A. — 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 | 080339762W0103010301AJ | Class A | Active |
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Manufacturer
- Manufacturer
- Bio-Optica Milano S.p.A.
- EUDAMED SRN
- IT-MF-000027525
Sources (3)
- EUDAMED f12fc146-962b-409f-8040-69697d817d58 61 fields · synced Jul 25, 2026
- EUDAMED 67cd0a01-fe2f-40c6-98ad-54ed9133f6c5 61 fields · synced May 18, 2026
- EUDAMED aad4c94f-a764-4273-a8bf-9bfbef2bdfe6 61 fields · synced May 18, 2026