Identity
- Trade Name
- TRANSTEK EUDAMED
- Device Name
- Disposable Blood Lancets EUDAMEDLancing Device EUDAMED
- Model / Reference
- Soft 30G 01-0130 EUDAMEDLDE4 02-2201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630136136 EUDAMED06945630136122 EUDAMED
- Basic UDI-DI
- 6945630101B9 EUDAMED6945630102BB EUDAMED
- Unit of Use DI
- 06945630136139 EUDAMED
- EMDN Code
- V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMEDEUDAMED
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
Transtek by Sterilance Medical (Suzhou) Inc. — 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 | 6945630101B9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sterilance Medical (Suzhou) Inc.
- EUDAMED SRN
- CN-MF-000002860
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 4f0773ce-113f-4e12-81ce-9dc77766eb27 61 fields · synced Jul 20, 2026
- EUDAMED e2780948-e09f-4d0d-8e5a-e49849d05b09 61 fields · synced May 17, 2026