← Back to catalogue
Spectra Optia®
FDA UDIEUDAMEDRef 11220Model Spectra Optia Single Needle Adaptor
Identity
- Trade Name
- Spectra Optia™ Single Needle Connector EUDAMEDSpectra Optia® FDA UDI
- Generic Name
- Blood transfer set FDA UDI
- Device Name
- Single-Needle Connector FDA UDI
- Model / Reference
- 11220 EUDAMEDFDA UDISpectra Optia Single Needle Adaptor EUDAMED
- Description
- Single-Needle Connector FDA UDI
Identifiers
- Catalog Number
- 11220 FDA UDI
- Primary DI / UDI-DI
- 05020583112209 EUDAMEDFDA UDI
- Basic UDI-DI
- 5020583OptiaSNConnectorH5 EUDAMED
- EMDN Code
- B030199 APHERESIS COLLECTION DEVICES - OTHER EUDAMED
- GMDN Term
- Blood transfer set FDA UDI
Classification
- Device Class
- Class IIa EUDAMED
- 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
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Blood transfer set
Spectra Optia® by Terumo BCT, Inc.. — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Blood transfer set.
- SteriPath Gen2, 23G, BD — MAGNOLIA MEDICAL TECHNOLOGIES, INC. · Class II
- Accessories — OriGen Biomedical, Inc. · Class I
- Rem Systems — CODAN US Corporation · Class II
- Accessories — OriGen Biomedical, Inc. · Class I
- SteriPath Gen2, 21G, 10ml — MAGNOLIA MEDICAL TECHNOLOGIES, INC. · Class II
- Steripath Micro — MAGNOLIA MEDICAL TECHNOLOGIES, INC. · Class II
- Accessories — OriGen Biomedical, Inc. · Class I
- SteriPath Gen2, Luer, BD — MAGNOLIA MEDICAL TECHNOLOGIES, INC. · Class II
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 | — | N/A | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Terumo BCT, Inc..
Sources (2)
- FDA UDI 4d529ca2-b973-4b80-9b96-12bf7da98e2d 36 fields · synced Jul 28, 2026
- EUDAMED e4faedcf-3c42-46e7-8eed-bcde85c3b8a2 61 fields · synced Jul 28, 2026