← Back to catalogue
FIABiomed Precisa Blood Glucose Monitoring System
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 3K-01-350034Model Precisa
Identity
- Trade Name
- FIABiomed Precisa Blood Glucose Monitoring System EUDAMED
- Device Name
- FIABiomed EUDAMED
- Model / Reference
- Precisa EUDAMED3K-01-350034 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260236851104 EUDAMED
- Basic UDI-DI
- B-04260236851104 EUDAMED
- EMDN Code
- W0101060101,W0201060102 EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
FIABiomed Precisa Blood Glucose Monitoring System by Hmd Biomedical Inc. — Class IVD Annex II List B — 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-04260236851104 | Class IVD Annex II List B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- HMD Biomedical Inc.
- EUDAMED SRN
- TW-MF-000032809
- Authorised Representative
- Luana Med. B.V. NL-AR-000002750
Sources (1)
- EUDAMED ee4a8d4d-ac61-4fe4-b063-f2b6ad88289f 61 fields · synced May 22, 2026