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VITREX lab
EUDAMEDClass IIa (EU MDR)
Ref 391513 IMPRESS PRO 26G 2.2mmRef 396513 IMPRESS PRO 21G 2.4mmRef Lite4 21G 1.8mmRef STEELRef 392513 IMPRESS PRO 30G 1.5mmRef 394513 IMPRESS PRO 26G 1.8mmRef Lite4 26G 1.8mmRef Lite4 28G 1.8mm
Identity
- Trade Name
- VITREX lab EUDAMED
- Device Name
- Disposable Safety Lancets EUDAMEDDisposable Steel Lancets EUDAMED
- Model / Reference
- 391513 IMPRESS PRO 26G 2.2mm EUDAMED396513 IMPRESS PRO 21G 2.4mm EUDAMEDLite4 21G 1.8mm EUDAMEDSTEEL EUDAMED392513 IMPRESS PRO 30G 1.5mm EUDAMED394513 IMPRESS PRO 26G 1.8mm EUDAMEDLite4 26G 1.8mm EUDAMEDLite4 28G 1.8mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630133944 EUDAMED16945630133982 EUDAMED16945630142670 EUDAMED16945630139595 EUDAMED16945630133951 EUDAMED16945630133968 EUDAMED16945630142687 EUDAMED16945630142694 EUDAMED
- Basic UDI-DI
- 6945630105BH EUDAMED6945630150BN EUDAMED
- Unit of Use DI
- 06945630133947 EUDAMED06945630133985 EUDAMED06945630142673 EUDAMED06945630139598 EUDAMED06945630133954 EUDAMED06945630133961 EUDAMED06945630142680 EUDAMED06945630142697 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMEDV010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark 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
Category: Blood lancet, single-use
VITREX lab by Sterilance Medical (Suzhou) Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Blood lancet, single-use.
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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 | 6945630105BH | 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 (8)
- EUDAMED 67976c2e-31c9-431b-885d-0be9077a7b0a 61 fields · synced Jul 30, 2026
- EUDAMED 476a7ca2-8e11-4fe2-8e20-dac176bfebb7 61 fields · synced May 16, 2026
- EUDAMED 24054bfe-bd05-45bc-bbab-24625068cb98 61 fields · synced May 16, 2026
- EUDAMED 780417a7-7e2f-49ec-ad7c-a906dad09da0 61 fields · synced May 17, 2026
- EUDAMED f4eab9d5-82cf-4c98-bd07-3776f1ccce8a 61 fields · synced May 18, 2026
- EUDAMED 60e1773e-cb96-417c-afdb-c161196b1e96 61 fields · synced May 18, 2026
- EUDAMED 859ec44f-77a0-42bf-bf5a-cc85b2c74f8c 61 fields · synced May 18, 2026
- EUDAMED ada853af-f258-474d-9b2b-5b48f3cac75d 61 fields · synced May 19, 2026