Identity
- Trade Name
- LotFancy EUDAMED
- Device Name
- Safety Blood Lancets EUDAMEDBlood Lancets EUDAMED
- Model / Reference
- SL-30-18M2 EUDAMEDBL-33G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975965293191 EUDAMED06975965294129 EUDAMED
- Basic UDI-DI
- 697122740SLYU EUDAMED697122740BLX9 EUDAMED
- Unit of Use DI
- 86975965293197 EUDAMED86975965294125 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMEDV010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden EUDAMEDGermany 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
Category: Blood lancet, single-use
LotFancy by Promisemed Hangzhou Meditech Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697122740SLYU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Promisemed Hangzhou Meditech Co., Ltd.
- EUDAMED SRN
- CN-MF-000008465
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 42b4fd98-e71c-4506-9e95-6941c6904c20 61 fields · synced Jul 18, 2026
- EUDAMED 90748b56-05f5-41a1-8e40-6606c66691cf 61 fields · synced May 17, 2026