Identity
- Trade Name
- SampLok® System with Hinged Lid EUDAMEDFDA UDI
- Generic Name
- Blood collection tube holder/needle FDA UDI
- Device Name
- SampLok EUDAMEDSampLok® System with Hinged Lid (Wider Bore), Clear Assembled with PP Luer, Individual Packaged Sterile; Intended to be used as a part of vacuum blood collection equipment for the collection of blood samples for various types of blood tests FDA UDI
- Model / Reference
- A100645 EUDAMEDFDA UDI
- Description
- SampLok® System with Hinged Lid (Wider Bore), Clear Assembled with PP Luer, Individual Packaged Sterile; Intended to be used as a part of vacuum blood collection equipment for the collection of blood samples for various types of blood tests FDA UDI
Identifiers
- Catalog Number
- A100645 FDA UDI
- Primary DI / UDI-DI
- 19555240401158 EUDAMEDFDA UDI
- Basic UDI-DI
- 955524040SSSR2 EUDAMED
- 510(k) Number
- K021941 FDA UDI
- FDA Product Code
- JKA FDA UDIFMI FDA UDI
- EMDN Code
- W0501010180 VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Blood collection tube holder/needle FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1675 FDA UDI880.5570 FDA UDI
- 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® System with Hinged Lid 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 | 955524040SSSR2 | 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 ffdd4a7d-49b5-4bd5-88b4-fc24faa9645c 61 fields · synced Jun 18, 2026
- FDA UDI b1c619af-4e42-46bc-98be-716284af33cc 37 fields · synced May 29, 2026