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DBS KIT - 20) Without Capillary Tubes
EUDAMEDClass IIa (EU MDR)
Ref KKIT-EXP20TSU-TFN-CBModel KKIT-EXP50TSU-LWP-CB
Identity
- Trade Name
- DBS KIT (TFN; 20) WITHOUT CAPILLARY TUBES EUDAMED
- Device Name
- Dried Blood Spot Collection Kit, Whatman Cards, with Capillary Tubes, 20 Tests. Single Use EUDAMED
- Model / Reference
- KKIT-EXP50TSU-LWP-CB EUDAMEDKKIT-EXP20TSU-TFN-CB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06009710130308 EUDAMED
- Basic UDI-DI
- 600971013DBSC5 EUDAMED
- EMDN Code
- W0501010299 CAPILLARY BLOOD COLLECTION DEVICES - OTHER EUDAMED
- Models / Variants
- Dbs Kit (tfn EUDAMED20) Without Capillary Tubes EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
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
DBS KIT - 20) Without Capillary Tubes by Lasec International (Pty) Ltd — Class IIa — MDR — listed in EUDAMED — 2 models — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 600971013DBSC5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Lasec International (Pty) Ltd
- EUDAMED SRN
- ZA-MF-000040804
- Authorised Representative
- TNMC Devices Llc HR-AR-000019582
Sources (1)
- EUDAMED 1858ff10-4290-4569-ae8e-74ee127d51a2 61 fields · synced Jul 20, 2026