Identity
- Trade Name
- TD-THIN Sterile lancets EUDAMEDTD-THIN Sterile Lancets (100pcs/box) FDA UDI
- Generic Name
- Blood lancing device tip FDA UDI
- Device Name
- Sterile Blood Lancet EUDAMED
- Model / Reference
- TD-5084 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04710636640162 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04710636640162 EUDAMED
- 510(k) Number
- K221419 FDA UDI
- FDA Product Code
- QRK 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
- Ireland 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Radiation Sterilization FDA UDI
TD-THIN Sterile lancets by Taidoc Technology Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04710636640162 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- TaiDoc Technology Corporation
- EUDAMED SRN
- TW-MF-000017956
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 3e038b8c-dd9e-4bc1-b33e-75642c9c8cb4 61 fields · synced Jun 19, 2026
- FDA UDI 3c8a8566-4341-4efd-a9ab-606bc4fb55c0 33 fields · synced May 30, 2026