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Incision Device (Gentleheel)
EUDAMEDClass IIa (EU MDR)
Ref PGH10X50Ref NGH10X50CRef PGH5X200Ref PGH4X250CRef PGH4X250Ref NGH4X250CRef NGH5X200Ref PGH10X50C
Identity
- Device Name
- Incision Device (Gentleheel) EUDAMED
- Model / Reference
- PGH10X50 EUDAMEDNGH10X50C EUDAMEDPGH5X200 EUDAMEDPGH4X250C EUDAMEDPGH4X250 EUDAMEDNGH4X250C EUDAMEDNGH5X200 EUDAMEDPGH10X50C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16931918176765 EUDAMED16931918178943 EUDAMED16931918178363 EUDAMED16931918190686 EUDAMED16931918159928 EUDAMED16931918177403 EUDAMED16931918187952 EUDAMED16931918157832 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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Also classified as Blood lancet, single-use.
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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 (8)
- EUDAMED 521dda05-da3a-4685-bd2c-2df16b58d0b5 61 fields · synced Sep 18, 2026
- EUDAMED 931e9e34-e943-474a-aea4-9a0376fab3e7 61 fields · synced May 16, 2026
- EUDAMED cd010303-61c2-4be5-af95-bc72fadeac2b 61 fields · synced May 16, 2026
- EUDAMED 6c8f81fd-6602-4231-9887-cf3ce1f22687 61 fields · synced May 17, 2026
- EUDAMED 2787726d-bf12-46d4-a0ae-366dea26cae0 61 fields · synced May 18, 2026
- EUDAMED 5ae3fb88-307d-4dad-948b-deb5bd350f0f 61 fields · synced May 18, 2026
- EUDAMED 98f4d3b9-a60f-40ad-b77a-ea7f3cb6f224 61 fields · synced May 19, 2026
- EUDAMED 00ed9992-7c31-475e-9443-840c83b7248b 61 fields · synced May 19, 2026