Identity
- Trade Name
- SPICTRA EUDAMED
- Device Name
- Arterial Blood Filter With Loop (Spictra) EUDAMED
- Model / Reference
- ADULT EUDAMEDM5AF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906172230004 EUDAMED
- Basic UDI-DI
- 890617223CPBABFD9 EUDAMEDB-08906172230004 EUDAMED
- EMDN Code
- C03010104 EXTRACORPOREAL CIRCULATION FILTERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Spictra by Medihub Sciencetec Private Limited — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 890617223CPBABFD9 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | 890617223CPBABFD9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medihub Sciencetec Private Limited
- EUDAMED SRN
- IN-MF-000007056
- Authorised Representative
- Meddevices Lifesciences B.V. NL-AR-000000594
Sources (2)
- EUDAMED b661e30e-6757-45db-9906-9cf9a463ba77 61 fields · synced Jun 18, 2026
- EUDAMED 29599464-0c06-4982-a1a5-39ae9e861869 61 fields · synced May 17, 2026