Identity
- Trade Name
- MEDISANA EUDAMED
- Device Name
- Blood Lancets EUDAMED
- Model / Reference
- Ⅰ Ⅱ Ⅲ EUDAMEDⅡ 28G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949517007529 EUDAMED
- Basic UDI-DI
- 694951700V8 EUDAMED
- EMDN Code
- V010402 LANCETS WITHOUT 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
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
Medisana by Shandong Lianfa Medical Plastic Products 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 | 694951700V8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shandong Lianfa Medical Plastic Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000028790
- Authorised Representative
- Linkfar Healthcare GmbH DE-AR-000005107
Sources (1)
- EUDAMED 58993d48-8dee-45fd-a803-3cd84704614e 61 fields · synced Jun 19, 2026