Identity
- Trade Name
- ergoLance EUDAMED
- Device Name
- safety lancet EUDAMED
- Model / Reference
- type 450 EUDAMED9195 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903999605216 EUDAMED
- Basic UDI-DI
- B-05903999605216 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Blood lancet, single-use
ergoLance by Htl Strefa S A — Class IIa — MDD — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05903999605216 | Class IIa | Active |
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Manufacturer
- Manufacturer
- HTL-Strefa S.A.
- EUDAMED SRN
- PL-MF-000002198
Sources (1)
- EUDAMED a9cffeba-f0d4-4d15-a0dc-37f3205b8d9a 61 fields · synced May 23, 2026