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Dbs Kit (tfn +1 more model
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 (tfn +1 more model 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