Identity
- Trade Name
- Safety SubCulture Unit 2 17G EUDAMEDSafety SubCulture Unit 2 (SCU2) FDA UDI
- Generic Name
- Blood/blood culture specimen transfer spike IVD, manual FDA UDI
- Device Name
- Safety SubCulture Unit EUDAMEDSCU2 is a needleless device used to obtain samples from blood culture bottles and to prevent the risk of a potential needlestick injury. FDA UDI
- Model / Reference
- A100722 EUDAMEDFDA UDI
- Description
- SCU2 is a needleless device used to obtain samples from blood culture bottles and to prevent the risk of a potential needlestick injury. FDA UDI
Identifiers
- Catalog Number
- A100722 FDA UDI
- Primary DI / UDI-DI
- 19555240401431 EUDAMEDFDA UDI
- Basic UDI-DI
- 955524040SCUSJY EUDAMED
- FDA Product Code
- LIB FDA UDI
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - OTHER EUDAMED
- GMDN Term
- Blood/blood culture specimen transfer spike IVD, manual FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2660 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Safety SubCulture Unit 2 17G by Itl Asia Pacific Sdn. Bhd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 955524040SCUSJY | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- ITL Asia Pacific Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000001570
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 030ccc01-c6d2-4529-824d-1d337887c4f0 61 fields · synced Jul 10, 2026
- FDA UDI 51638717-4abe-4a00-b32d-3b8d04c331e5 36 fields · synced May 30, 2026