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Tud K3 Edta 9ml
EUDAMEDClass A (EU MDR)
Ref 161090008AModel EDTATUBE
by Tud Sdn Bhd
Identity
- Trade Name
- TUD K3 EDTA 9ML EUDAMED
- Model / Reference
- EDTATUBE EUDAMED161090008A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555984601596 EUDAMED
- Basic UDI-DI
- 955598460EDTATUBELG EUDAMED
- EMDN Code
- W050301020101 SAMPLES ANALYSES, PLASTIC TUBES WITH ADDITIVES EUDAMED
Classification
- Device Class
- Class A EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: General specimen collection kit
Tud K3 Edta 9ml by Tud Sdn Bhd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 955598460EDTATUBELG | Class A | Active |
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Manufacturer
- Manufacturer
- Tud Sdn Bhd
- EUDAMED SRN
- MY-MF-000050104
- Authorised Representative
- P&J PTE OÜ EE-AR-000049689
Sources (1)
- EUDAMED 549a4a45-d01a-4bd5-8c13-661144bf77b3 61 fields · synced Jun 18, 2026