Identity
- Trade Name
- SampLok® Adapter Cap EUDAMEDFDA UDI
- Generic Name
- Blood collection tube holder, single-use FDA UDI
- Device Name
- Adapter Cap EUDAMEDSampLok® Adaptor Cap, Clear, Bulk, Non-sterile; Intended to facilitate collection of blood sample into either a culture bottle or standard vacuum blood tubes FDA UDI
- Model / Reference
- A100706 EUDAMEDFDA UDI
- Description
- SampLok® Adaptor Cap, Clear, Bulk, Non-sterile; Intended to facilitate collection of blood sample into either a culture bottle or standard vacuum blood tubes FDA UDI
Identifiers
- Catalog Number
- A100706 FDA UDI
- Primary DI / UDI-DI
- 19555240400205 EUDAMEDFDA UDI
- Basic UDI-DI
- 955524040ACNSED EUDAMED
- 510(k) Number
- K000777 FDA UDI
- FDA Product Code
- JKA FDA UDI
- EMDN Code
- W0501010180 VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Blood collection tube holder, single-use FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1675 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
SampLok® Adapter Cap 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 | 955524040ACNSED | 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 15c0e344-7e07-4b4b-b0d0-5e8f8f095843 61 fields · synced Jul 10, 2026
- FDA UDI 76a16c84-e689-42cb-960d-f79618cdfd74 37 fields · synced May 30, 2026