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Safety Lancet FleX 28G
EUDAMEDClass IIa (EU MDR)
Ref GD104124Model XA1, XA2, XA3, XA4, XA5, XA6, XA1 Pro, XA3 Pro, XA5 Pro, XA11 Pro
Identity
- Trade Name
- Safety Lancet FleX 28G 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 EUDAMEDGD104124 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16934047901444 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 28G by Ningbo Medsun Medical Co., Ltd. — 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 | 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 (1)
- EUDAMED af2a2095-830f-4ab8-ba1f-7362d194ba93 61 fields · synced Jun 18, 2026