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Adjustable Blood Lancet
EUDAMEDClass IIa (EU MDR)
Ref XA5 Pro 23GModel XA1, XA2, XA3, XA4, XA5, XA6, XA1 Pro, XA3 Pro, XA5 Pro, XA11 ProRef XA5 Pro 26GRef XA5 Pro 28G
Identity
- Trade Name
- Adjustable Blood Lancet EUDAMED
- Device Name
- Blood Lancet for single use EUDAMED
- Model / Reference
- XA1, XA2, XA3, XA4, XA5, XA6, XA1 Pro, XA3 Pro, XA5 Pro, XA11 Pro EUDAMEDXA5 Pro 23G EUDAMEDXA5 Pro 26G EUDAMEDXA5 Pro 28G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16934047905626 EUDAMED16934047905633 EUDAMED16934047905640 EUDAMED
- Basic UDI-DI
- 69340479EU01XALQ 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
Adjustable Blood 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
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- 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 | 69340479EU01XALQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo Medsun Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000011842
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED f5094c5b-3348-4a6f-8784-e51841ca5eb1 61 fields · synced Jul 23, 2026
- EUDAMED 6dd4c8f3-4a3c-4e2f-b815-4708c0853e05 61 fields · synced May 17, 2026
- EUDAMED 8c48b4f4-2fcb-4848-86a5-c332971615f7 61 fields · synced May 18, 2026