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Disposable Safety Lancets
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 1.6 21G*2.2Model 1.5 21G*2.2Ref 1.5 30G*1.8Ref 1.5 21G*2.2Ref 1.5 23G*1.8Ref 1.5 23G*2.2Ref 1.6 28G*1.8Ref 1.5 26G*1.8
Identity
- Trade Name
- Disposable Safety Lancets EUDAMED
- Device Name
- Disposable Safety Lancets EUDAMED
- Model / Reference
- 1.5 21G*2.2 EUDAMED1.6 21G*2.2 EUDAMED1.5 30G*1.8 EUDAMED1.5 21G*2.2 EUDAMED1.5 23G*1.8 EUDAMED1.5 23G*2.2 EUDAMED1.6 28G*1.8 EUDAMED1.5 26G*1.8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16971517661798 EUDAMED16971517664003 EUDAMED16971517664065 EUDAMED16971517661781 EUDAMED16971517664041 EUDAMED16971517661804 EUDAMED16971517664027 EUDAMED
- Basic UDI-DI
- 697151766safetylancets1R2 EUDAMED
- Direct Marketing DI
- 16971517661798 EUDAMED16971517664003 EUDAMED16971517664065 EUDAMED16971517661781 EUDAMED16971517664041 EUDAMED16971517661804 EUDAMED16971517664027 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Disposable Safety Lancets by Suzhou Kyuan Medical Apparatus Co., Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Also classified as Blood lancet, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221778 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697151766safetylancets1R2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Suzhou Kyuan Medical Apparatus Co., Ltd
- EUDAMED SRN
- CN-MF-000021229
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (8)
- EUDAMED cb4f21d7-3ec6-4a5b-88f0-e209787c5fe9 61 fields · synced Oct 6, 2026
- EUDAMED 7b24fea0-c2d9-473c-aa59-27e9121ba52e 61 fields · synced May 16, 2026
- EUDAMED aeb68906-2f28-4bbb-bda0-bdd27695ae42 61 fields · synced May 17, 2026
- EUDAMED 12e79835-de5b-4713-bd71-41e9a2127f0e 61 fields · synced May 17, 2026
- EUDAMED 2b407649-22a1-4b67-8760-caccce739810 61 fields · synced May 17, 2026
- EUDAMED c19e9b37-3833-466e-90b0-50009a2df755 61 fields · synced May 18, 2026
- EUDAMED 7481a083-3d48-4f82-8902-f3af0cd158d8 61 fields · synced May 18, 2026
- FDA 510(k) K221778 1 fields · synced May 18, 2026