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FreeStyle Lancing Device II
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref AT1710EA392Model AL-0710-00-00*Ref AT1710EA393510(k) K221613
Identity
- Trade Name
- FreeStyle Lancing Device II EUDAMED
- Device Name
- FreeStyle Lancing Device II EUDAMED
- Model / Reference
- AL-0710-00-00* EUDAMEDAT1710EA392 EUDAMEDAT1710EA393 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05016189039217 EUDAMED05016189039316 EUDAMED
- Basic UDI-DI
- 5016189FREESTYLEJR EUDAMED
- 510(k) Number
- K221613 FDA 510(k)
- FDA Product Code
- QRL FDA 510(k)
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4850 FDA 510(k)
- Regulation Number
- 878.4850 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
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
FreeStyle Lancing Device II by Owen Mumford Ltd — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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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 | K221613 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 5016189FREESTYLEJR | Class I | Active |
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Manufacturer
- Manufacturer
- Owen Mumford Ltd
- EUDAMED SRN
- GB-MF-000021000
- Authorised Representative
- Owen Mumford GmbH DE-AR-000020700
Sources (3)
- EUDAMED 606fa0e8-9a79-43e0-baa2-f613d5414bb1 61 fields · synced Jul 17, 2026
- EUDAMED 627f79ed-4da4-4a4f-bbec-b3468894dfd6 61 fields · synced May 17, 2026
- FDA 510(k) K221613 24 fields · synced May 18, 2026