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Safety Lancet FleX 23G
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref GD104122Model XA1, XA2, XA3, XA4, XA5, XA6, XA1 Pro, XA3 Pro, XA5 Pro, XA11 Pro
Identity
- Trade Name
- Safety Lancet FleX 23G EUDAMED
- Device Name
- Blood Lancet for single use EUDAMED
- Model / Reference
- XA1, XA2, XA3, XA4, XA5, XA6, XA1 Pro, XA3 Pro, XA5 Pro, XA11 Pro EUDAMEDGD104122 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16934047901475 EUDAMED
- Basic UDI-DI
- 69340479EU01XALQ EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Safety Lancet FleX 23G by Ningbo Medsun Medical Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
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 | K242627 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K242316 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K222090 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69340479EU01XALQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo Medsun Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000011842
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 249330d4-9129-4b59-acfc-c5e2012a107c 61 fields · synced Jul 16, 2026
- FDA 510(k) K242627 1 fields · synced May 18, 2026