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Spectra Optia®
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 12220Model Spectra Optia Exchange Sets
Identity
- Trade Name
- Spectra Optia™ Exchange Set EUDAMEDSpectra Optia® FDA UDI
- Generic Name
- Apheresis system tubing set FDA UDI
- Device Name
- Exchange Sets FDA UDI
- Model / Reference
- 12220 EUDAMEDFDA UDISpectra Optia Exchange Sets EUDAMED
- Description
- Exchange Sets FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05020583122208 EUDAMEDFDA UDI
- Basic UDI-DI
- 5020583OptiaExchBF EUDAMED
- FDA Product Code
- GKT FDA UDI
- EMDN Code
- B030199 APHERESIS COLLECTION DEVICES - OTHER EUDAMED
- GMDN Term
- Apheresis system tubing set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9245 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Apheresis system tubing set
Spectra Optia® by Terumo BCT, Inc.. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Terumo BCT, Inc..
Sources (2)
- FDA UDI b9498bdb-2e74-4bde-9ce9-b226ff007728 35 fields · synced Jul 30, 2026
- EUDAMED 4bfec05f-6528-4db7-8c7b-9b265fcf0725 61 fields · synced Jul 30, 2026