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Js
EUDAMEDClass IIa (EU MDR)
Ref impress Pro 26G 1.8mmRef "Lite3 26G 2.4mm"Ref impress Pro 21G 1.8mmRef 11-0121Ref 11-0211Ref 11-0122Ref 11-0123Ref 11-0124
Identity
- Trade Name
- JS EUDAMED
- Device Name
- Disposable Safety Lancets EUDAMEDDisposable Surgical Blades EUDAMED
- Model / Reference
- impress Pro 26G 1.8mm EUDAMED"Lite3 26G 2.4mm" EUDAMEDimpress Pro 21G 1.8mm EUDAMED11-0121 EUDAMED11-0211 EUDAMED11-0122 EUDAMED11-0123 EUDAMED11-0124 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630141406 EUDAMED16945630141383 EUDAMED16945630141390 EUDAMED16945630143899 EUDAMED16945630143851 EUDAMED16945630143905 EUDAMED16945630143912 EUDAMED16945630143929 EUDAMED
- Basic UDI-DI
- 6945630105BH EUDAMED6945630111BC EUDAMED
- Unit of Use DI
- 06945630141409 EUDAMED06945630141386 EUDAMED06945630141393 EUDAMED06945630143892 EUDAMED06945630143854 EUDAMED06945630143908 EUDAMED06945630143915 EUDAMED06945630143922 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMEDV010302 BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa 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
Js by Sterilance Medical (Suzhou) Inc. — 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
- DropSafe Medlance Plus, safety lancets — HTL STREFA S A · Class II
- Safety Lancet (28G) — Shandong Lianfa Medical Plastic Products CO., LTD · Class II
- Twist Lancet (23G) — 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 | 6945630105BH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sterilance Medical (Suzhou) Inc.
- EUDAMED SRN
- CN-MF-000002860
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (8)
- EUDAMED 22d6290b-850b-483d-bbfc-164c1203756b 61 fields · synced Sep 30, 2026
- EUDAMED 61e5bfa3-139b-4bb1-a274-1c6daa0ae3d6 61 fields · synced May 18, 2026
- EUDAMED 53b7cc9d-38db-457b-a717-6a12d2e2d3d7 61 fields · synced May 18, 2026
- EUDAMED 48cab9ab-a7b6-4f3b-b51a-6fa265a04e54 61 fields · synced Jun 18, 2026
- EUDAMED b84687d9-a097-4a15-8dc1-6f7bd784933f 61 fields · synced Jul 10, 2026
- EUDAMED 90527851-9814-41e0-a2d3-5939a0d2f033 61 fields · synced Jul 10, 2026
- EUDAMED 4ba06c84-f111-4a1e-bd35-898c99de574d 61 fields · synced Jul 21, 2026
- EUDAMED 289867c6-79f1-4061-86ca-ebc8a4ff7fc8 61 fields · synced Aug 2, 2026