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Spectra Optia™ SPD-C Connection Set
EUDAMEDClass IIa (EU MDR)
Ref 12200Model Spectra Optia SPD-C Connection Set
Identity
- Trade Name
- Spectra Optia™ SPD-C Connection Set EUDAMED
- Model / Reference
- Spectra Optia SPD-C Connection Set EUDAMED12200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05020583122000 EUDAMED
- Basic UDI-DI
- 5020583OptiaSPDCSetNC EUDAMED
- EMDN Code
- B030199 APHERESIS COLLECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Spectra Optia™ SPD-C Connection Set by Terumo BCT, Inc.. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5020583OptiaSPDCSetNC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Terumo BCT, Inc.
- EUDAMED SRN
- US-MF-000001069
- Authorised Representative
- Terumo BCT Europe N.V. BE-AR-000001030
Sources (1)
- EUDAMED 564801b1-8989-4a02-8744-c69f8a619ba1 61 fields · synced Jul 9, 2026