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Adjustable Blood Lancet
EUDAMEDClass IIa (EU MDR)
Ref XA5 Pro 21GModel XA1, XA2, XA3, XA4, XA5, XA6, XA1 Pro, XA3 Pro, XA5 Pro, XA11 Pro
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 21G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16934047905619 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.
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- 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 (1)
- EUDAMED 2ab93d78-5bb7-4e17-8c43-d9379c0afeea 61 fields · synced Jun 18, 2026