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STERiLANCE
EUDAMEDClass IIa (EU MDR)
Ref 05-2926A Elite Pro 26G 1.3mm/1.8mm/2.3mm
Identity
- Trade Name
- STERiLANCE EUDAMED
- Device Name
- Disposable Safety Lancets EUDAMED
- Model / Reference
- 05-2926A Elite Pro 26G 1.3mm/1.8mm/2.3mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630133241 EUDAMED
- Basic UDI-DI
- 6945630105BH EUDAMED
- Unit of Use DI
- 06945630133244 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
STERiLANCE 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 | 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 (1)
- EUDAMED 468adea1-4a2b-47fc-8b84-3da6a472df76 61 fields · synced May 23, 2026