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GLUCO-CARE Safety Lancets
EUDAMEDClass IIa (EU MDR)
Ref XLII2618Model XLII, XL-B, XL-C, XL-D, XL-ERef XLII2118Ref XLB2818Ref XLII2128Ref XLB2324
Identity
- Trade Name
- GLUCO-CARE Safety Lancets EUDAMED
- Device Name
- Lancet EUDAMED
- Model / Reference
- XLII, XL-B, XL-C, XL-D, XL-E EUDAMEDXLII2618 EUDAMEDXLII2118 EUDAMEDXLB2818 EUDAMEDXLII2128 EUDAMEDXLB2324 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950383618108 EUDAMED06950383618016 EUDAMED06950383618191 EUDAMED06950383618047 EUDAMED06950383618160 EUDAMED
- Basic UDI-DI
- 69503836XL0201CANM EUDAMED
- Unit of Use DI
- 06950383618092 EUDAMED06950383618009 EUDAMED06950383618184 EUDAMED06950383618030 EUDAMED06950383618153 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
GLUCO-CARE Safety Lancets by Hebei Xinle Sci&Tech 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 | 69503836XL0201CANM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hebei Xinle Sci&Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000016692
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (5)
- EUDAMED 8a94744b-abb4-4740-8f94-839deb5159e6 61 fields · synced Jul 28, 2026
- EUDAMED 6ae3056a-f332-448d-86ec-b9c985e8cc49 61 fields · synced May 16, 2026
- EUDAMED aa07e2c2-b63f-4c9e-8ecd-e263b517c199 61 fields · synced May 17, 2026
- EUDAMED c5dc1ae9-9133-4406-9920-6a5c759fd78f 61 fields · synced May 18, 2026
- EUDAMED 519a6b0b-58a3-4a23-95ea-035174500c5b 61 fields · synced May 18, 2026