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Glucose-6-Phosphate Dehydrogenase
EUDAMEDClass IVD General (EU MDR)
Ref 12603Ref 21603
Identity
- Device Name
- GLUCOSE-6-PHOSPHATE DEHYDROGENASE EUDAMED
- Model / Reference
- 12603 EUDAMED21603 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287109337 EUDAMED08435287108965 EUDAMED
- Basic UDI-DI
- B-08435287109337 EUDAMEDB-08435287108965 EUDAMED
- EMDN Code
- W01010199 ENZYMES - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Glucose-6-Phosphate Dehydrogenase by Biosystems S.a. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08435287109337 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (2)
- EUDAMED 44e22b18-9f5e-45c3-a63f-f289ecf815a0 61 fields · synced Jul 11, 2026
- EUDAMED af207eee-6eaf-460d-baf5-f86083416c2d 61 fields · synced May 17, 2026