Identity
- Trade Name
- SampLok®Sampling Kit 10mL EUDAMEDSampLok® Sampling Kit 10mL FDA UDI
- Generic Name
- Blood/blood culture specimen transfer spike IVD, manual FDA UDI
- Device Name
- SampLok Sampling Kit EUDAMEDSampLok® Sampling Kit (SSK): SSK-Mk3-10mL is used to transfer samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests. FDA UDI
- Model / Reference
- A100750 EUDAMEDFDA UDI
- Description
- SampLok® Sampling Kit (SSK): SSK-Mk3-10mL is used to transfer samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests. FDA UDI
Identifiers
- Catalog Number
- A100750 FDA UDI
- Primary DI / UDI-DI
- 09555240400734 EUDAMEDFDA UDI
- Basic UDI-DI
- 955524040SSKSLJ EUDAMED
- FDA Product Code
- KSS 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
- 864.9050 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
SampLok®Sampling Kit 10mL 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 | 955524040SSKSLJ | 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 22e21823-71a3-4c6a-86d4-33d69943ae88 61 fields · synced Jun 19, 2026
- FDA UDI e4c5688d-e003-437a-80fa-193eb548862d 37 fields · synced May 29, 2026