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Sterilance Disposable Safety Lancet
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 05-052618 Press 26G 1.8mm
Identity
- Trade Name
- Sterilance Disposable Safety Lancet EUDAMED
- Device Name
- Disposable Safety Lancets EUDAMED
- Model / Reference
- 05-052618 Press 26G 1.8mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630117418 EUDAMED
- Basic UDI-DI
- 6945630105BH EUDAMED
- Unit of Use DI
- 06945630117411 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa 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
Sterilance Disposable Safety Lancet by Sterilance Medical (Suzhou) Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221521 | Class IIa | Active |
| 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 (2)
- EUDAMED 7bf133ee-1dc8-48b1-b240-4bf8f5b24889 61 fields · synced Jul 15, 2026
- FDA 510(k) K221521 1 fields · synced May 18, 2026