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Assay Cup/Assay Tip
EUDAMEDClass A (EU MDR)
Ref 032120111Model 1×6×105、6×6×105、12×2×105Ref 0320510001Ref 0320510002
Identity
- Trade Name
- Assay Cup/Assay Tip EUDAMED
- Device Name
- Assay Cup/Assay Tip EUDAMED
- Model / Reference
- 1×6×105、6×6×105、12×2×105 EUDAMED032120111 EUDAMED0320510001 EUDAMED0320510002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978139071557 EUDAMED06975984062594 EUDAMED06975984062600 EUDAMED
- Basic UDI-DI
- 69703416803205085JV EUDAMED
- EMDN Code
- W050301020180 SAMPLES ANALYSES, PLASTIC TUBES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
New Device
No
EUDAMED
Assay Cup/Assay Tip by Shenzhen Lifotronic Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69703416803205085JV | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (3)
- EUDAMED 9921d1c2-f870-4366-a861-48a4ea1a2a2b 61 fields · synced Sep 17, 2026
- EUDAMED 15fba085-f82f-43ec-a449-faf58b0e3fed 61 fields · synced May 17, 2026
- EUDAMED 8fb47e47-f59d-4b20-8f9f-9a82c9c47cfc 61 fields · synced May 19, 2026