← Back to catalogue
Acti-Lance
EUDAMEDClass IIa (EU MDR)
Ref 6817Model Type 610Ref 6838Ref 6815Ref 9226Ref 6816Ref 6804Ref 6813Ref 6831
Identity
- Trade Name
- Acti-Lance EUDAMED
- Device Name
- Safety Lancet EUDAMED
- Model / Reference
- Type 610 EUDAMED6817 EUDAMED6838 EUDAMED6815 EUDAMED9226 EUDAMED6816 EUDAMED6804 EUDAMED6813 EUDAMED6831 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903999609160 EUDAMED05903999609337 EUDAMED05903999607784 EUDAMED05903999608231 EUDAMED05903999607791 EUDAMED05903999608866 EUDAMED05903999607760 EUDAMED05903999609269 EUDAMED
- Basic UDI-DI
- 590799609610MF EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMEDFinland EUDAMEDCzechia EUDAMEDLithuania 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
Acti-Lance by Htl Strefa S A — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Blood lancet, single-use.
- Contact Activated Safety Lancet — NINGBO MEDSUN MEDICAL CO., LTD. · Class IIa
- TysonBio — Shandong Lianfa Medical Plastic Products CO., LTD · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Safety Lancet (25G) — Shandong Lianfa Medical Plastic Products CO., LTD · Class II
- Safety Lancet (23G) — Shandong Lianfa Medical Plastic Products CO., LTD · Class II
- STERiLANCE — Sterilance Medical (Suzhou) Inc. · Class IIa
- Lite3 — Sterilance Medical (Suzhou) Inc. · Class IIa
- Safety Lancet (28G) — Shandong Lianfa Medical Plastic Products CO., LTD · 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 | 590799609610MF | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- HTL-Strefa S.A.
- EUDAMED SRN
- PL-MF-000002198
Sources (8)
- EUDAMED 6f4d3fb8-4a08-45ad-932f-94feb21b2c9f 61 fields · synced Sep 17, 2026
- EUDAMED 99b617c3-e375-4764-9005-0e567db7b252 61 fields · synced May 16, 2026
- EUDAMED bf968963-6f36-413d-aa32-b187efd3159d 61 fields · synced May 17, 2026
- EUDAMED cde73eaf-c51c-47b6-99ca-97c5cc22efac 61 fields · synced May 17, 2026
- EUDAMED d37c822d-30d6-4408-b0cf-c4572c1a63b2 61 fields · synced May 17, 2026
- EUDAMED c60ee901-cd06-442f-8d11-42e793cc6d2f 61 fields · synced May 18, 2026
- EUDAMED 8933cfe9-fa69-4cab-9756-1b28091b864b 61 fields · synced May 18, 2026
- EUDAMED 5638b7db-7bf9-4881-a034-b758ee77a02a 61 fields · synced Jul 9, 2026