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Elinic
EUDAMEDClass IIa (EU MDR)
Ref PA-28G 1.8mmModel PA PA2 NPA APARef Ⅱ-28GModel Ⅰ Ⅱ Ⅲ
Identity
- Trade Name
- ELINIC EUDAMED
- Device Name
- safety lancets EUDAMEDBlood Lancets EUDAMED
- Model / Reference
- PA PA2 NPA APA EUDAMEDPA-28G 1.8mm EUDAMEDⅠ Ⅱ Ⅲ EUDAMEDⅡ-28G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949517008045 EUDAMED06949517006621 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
- Spain 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
Elinic 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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- DropSafe Medlance Plus, safety lancets — HTL STREFA S A · Class II
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 (2)
- EUDAMED c2f36953-e3df-449f-be54-bef7016747f5 61 fields · synced Oct 6, 2026
- EUDAMED 0f18a0d5-d7f5-4cdb-9ce0-d217b4a078fc 61 fields · synced May 17, 2026