Identity
- Device Name
- DISPOSABLE STERILE LANCET EUDAMED
- Model / Reference
- II EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16975522992052 EUDAMED
- Basic UDI-DI
- 697552299SLA200QM EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Disposable Sterile Lancet by Tianjin Rilifine Medical Device Co., Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
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 | K222055 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K222246 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697552299SLA200QM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Tianjin Rilifine Medical Device Co., Ltd
- EUDAMED SRN
- CN-MF-000026981
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED 4c8d130e-91b1-49ed-b45f-6d98c8f80f6e 61 fields · synced Oct 6, 2026
- FDA 510(k) K222055 1 fields · synced May 18, 2026