Identity
- Trade Name
- AXIFLOW EUDAMED
- Device Name
- DBS CARD (Specimen Collection Card) EUDAMED
- Model / Reference
- X-DBS EUDAMEDAXI-DBS-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89080246910018 EUDAMED
- Basic UDI-DI
- 890802469100185 EUDAMED
- EMDN Code
- W0501010199,W0501010299 EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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
Axiflow by Axiflow Biotech Private Limited — 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 | 890802469100185 | Class A | Active |
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Manufacturer
- Manufacturer
- Axiflow Biotech Private Limited
- EUDAMED SRN
- IN-MF-000042655
- Authorised Representative
- Europecert UG (haftungsbeschränkt) DE-AR-000004974
Sources (1)
- EUDAMED f2ae0035-ea1d-4840-90b7-8ac4db97d31c 61 fields · synced Jul 20, 2026