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Twist-off Lancet
EUDAMEDClass IIa (EU MDR)
Ref NoModel DI, DII, DIII, DV, DVI, DVII, DVIII, DIX
Identity
- Device Name
- Twist-off Lancet EUDAMED
- Model / Reference
- DI, DII, DIII, DV, DVI, DVII, DVIII, DIX EUDAMEDNo EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957138614255 EUDAMED
- Basic UDI-DI
- 69571386TOL11YJ EUDAMED
- Unit of Use DI
- 56957138614250 EUDAMED
- EMDN Code
- V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
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
Twist-off Lancet by Tianjin Huahong Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — 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 | 69571386TOL11YJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Tianjin Huahong Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000015849
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 73c51a6e-8852-4281-a02d-f7bdd8d901bd 61 fields · synced Jun 18, 2026