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COMFORT Sicherheitslanzette
EUDAMEDClass IIa (EU MDR)
Ref 13100345Model XY1,XY2,XY3,XY4,XY1Blade,XY2Blade,XY3Blade,XY4Blade
Identity
- Trade Name
- COMFORT Sicherheitslanzette EUDAMED
- Device Name
- Blood Lancet for single use EUDAMED
- Model / Reference
- XY1,XY2,XY3,XY4,XY1Blade,XY2Blade,XY3Blade,XY4Blade EUDAMED13100345 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16934047940191 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
- Germany 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
Category: Blood lancet, single-use
COMFORT Sicherheitslanzette by Ningbo Medsun Medical Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 4ff9dfc4-c081-42ff-b11a-229592342dc5 61 fields · synced Jun 18, 2026