Identity
- Trade Name
- LotFancy EUDAMEDFDA UDI
- Generic Name
- Autoinjector needle FDA UDI
- Device Name
- Blood Lancets EUDAMEDThe products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. There has several models. Different models are distinguished by needle gauge and length. The Blood Lancet consists of needle tube and needle hub. The products are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1. FDA UDI
- Model / Reference
- BL-30G EUDAMED11G-2091-K FDA UDI
- Description
- The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. There has several models. Different models are distinguished by needle gauge and length. The Blood Lancet consists of needle tube and needle hub. The products are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971227402547 EUDAMEDFDA UDI
- Basic UDI-DI
- 697122740BLX9 EUDAMED
- Unit of Use DI
- 86971227402543 EUDAMED
- EMDN Code
- V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
- GMDN Term
- Autoinjector needle FDA UDI
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
LotFancy by Promisemed Hangzhou Meditech Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697122740BLX9 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 eb2a281e-6913-448a-816b-84e831ae9fc9 61 fields · synced Oct 7, 2026
- FDA UDI a42e4789-4079-43ea-85b2-b1dbc7587268 33 fields · synced May 27, 2026