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Twist-off lancet (use with lancing device)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref NoModel I, II, III, V, VI, VII, VIII, IX
Identity
- Trade Name
- Lite Touch FDA UDI
- Generic Name
- Blood lancing device tip FDA UDI
- Device Name
- Twist-off lancet (use with lancing device) EUDAMED
- Model / Reference
- I, II, III, V, VI, VII, VIII, IX EUDAMEDNo EUDAMEDIA,28G FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06957138606403 EUDAMEDFDA UDI
- Basic UDI-DI
- 69571386TOL01YF EUDAMED
- Unit of Use DI
- 56957138606408 EUDAMED
- FDA Product Code
- QRL FDA UDIQRK FDA UDI
- EMDN Code
- V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
- GMDN Term
- Blood lancing device tip FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4850 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Twist-off lancet (use with lancing device) by Tianjin Huahong Technology Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69571386TOL01YF | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED 2738164b-ee4f-4d29-bef8-c0f3d421eead 61 fields · synced Jun 17, 2026
- FDA UDI 290c3095-fd97-49bd-90e1-6debf3c0abd8 32 fields · synced May 29, 2026