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GlucoSmant
EUDAMEDClass IIa (EU MDR)
Ref PA 28G 1.8mmModel PA PA2 NPA APARef PA 30G 1.5mmRef II 28GModel Ⅰ Ⅱ Ⅲ
Identity
- Trade Name
- GlucoSmant EUDAMED
- Device Name
- safety lancets EUDAMEDBlood Lancets EUDAMED
- Model / Reference
- PA PA2 NPA APA EUDAMEDPA 28G 1.8mm EUDAMEDPA 30G 1.5mm EUDAMEDⅠ Ⅱ Ⅲ EUDAMEDII 28G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949517008182 EUDAMED06949517008199 EUDAMED06949517009431 EUDAMED
- Basic UDI-DI
- 69495170PAHH EUDAMED694951700V8 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMEDV010402 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
Category: Blood lancet, single-use
GlucoSmant by Shandong Lianfa Medical Plastic Products 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 | 69495170PAHH | 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 (3)
- EUDAMED 1f789354-7f2a-4def-991c-bda4deaee1bf 61 fields · synced Oct 6, 2026
- EUDAMED 25d4f86a-07b9-46a0-8ae1-055a86c2f638 61 fields · synced May 17, 2026
- EUDAMED 7ba7daa5-9684-4721-99f6-dfe096669a5e 61 fields · synced May 18, 2026