Identity
- Trade Name
- Cardinal FDA UDI
- Generic Name
- Blood lancet, single-use FDA UDI
- Device Name
- Incision Device (Gentleheel) EUDAMEDgentleheel_for_preemie_ETO_500EA/CS FDA UDI
- Model / Reference
- GHP10X50 EUDAMEDFDA UDI
- Description
- gentleheel_for_preemie_ETO_500EA/CS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16931918137711 EUDAMEDFDA UDI
- Basic UDI-DI
- 69319181F028L7 EUDAMED
- FDA Product Code
- FMK FDA UDI
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
- GMDN Term
- Blood lancet, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4850 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood lancet, single-use
Incision Device (Gentleheel) by GRI Medical & Electronic Technology Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Blood lancet, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69319181F028L7 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED 4b4bed5a-e4ff-45c3-be8a-20aa0c268c71 61 fields · synced Sep 18, 2026
- FDA UDI 67bc3da6-8c46-41b8-a586-9a37e4bd5902 34 fields · synced May 30, 2026