Identity
- Device Name
- Incision Device (Gentleheel) EUDAMED
- Model / Reference
- MPGH10X50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16931918149509 EUDAMED
- Basic UDI-DI
- 69319181F028L7 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
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
Category: Blood lancet, single-use
Incision Device (Gentleheel) by GRI Medical & Electronic Technology 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 | 69319181F028L7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- GRI Medical & Electronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000004203
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 5dd83a69-73d3-4991-98af-501f880be386 61 fields · synced Sep 18, 2026