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Spictra
EUDAMEDClass IIa (EU MDR)
Ref M22MPModel Myocardial Protection System M22MP
Identity
- Trade Name
- SPICTRA EUDAMED
- Device Name
- Myocardial protection system EUDAMED
- Model / Reference
- Myocardial Protection System M22MP EUDAMEDM22MP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906172230080 EUDAMED
- Basic UDI-DI
- B-08906172230080 EUDAMED
- EMDN Code
- C030102 CARDIOPLEGIA SOLUTION ADMINISTRATION KITS 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Spictra by Medihub Sciencetec Private Limited — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08906172230080 | 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 (1)
- EUDAMED ab275626-c22f-4f8b-aded-a629c5d90684 61 fields · synced Jun 18, 2026