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Sterilné lancety
EUDAMEDClass IIa (EU MDR)
Ref XY1-30Model XY1,XY2,XY3,XY4,XY1Blade,XY2Blade,XY3Blade,XY4Blade
Identity
- Trade Name
- Sterilné lancety EUDAMED
- Device Name
- Blood Lancet for single use EUDAMED
- Model / Reference
- XY1,XY2,XY3,XY4,XY1Blade,XY2Blade,XY3Blade,XY4Blade EUDAMEDXY1-30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16934047905824 EUDAMED
- Basic UDI-DI
- 69340479EU01RQ EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Slovakia 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
Sterilné lancety 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 | 69340479EU01RQ | 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 64226148-5ce7-43ec-8ca0-cc6dbb2b328f 61 fields · synced Jun 18, 2026