← Back to catalogue
Contact Activated Safety Lancet
EUDAMEDClass IIa (EU MDR)
Ref XY1 21GModel XY1,XY2,XY3,XY4,XY1Blade,XY2Blade,XY3Blade,XY4Blade
Identity
- Trade Name
- Contact Activated Safety Lancet EUDAMED
- Device Name
- Blood Lancet for single use EUDAMED
- Model / Reference
- XY1,XY2,XY3,XY4,XY1Blade,XY2Blade,XY3Blade,XY4Blade EUDAMEDXY1 21G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16934047905558 EUDAMED
- Basic UDI-DI
- 69340479EU01RQ EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Contact Activated Safety Lancet by Ningbo Medsun Medical Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Blood lancet, single-use.
- 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
- DropSafe Medlance Plus, safety lancets — HTL STREFA S A · Class II
- 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 | 69340479EU01RQ | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ningbo Medsun Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000011842
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 0f844dad-559c-4a77-b8db-c170a17e321e 61 fields · synced Jun 19, 2026