Identity
- Trade Name
- HandyRay-Lite EUDAMEDFDA UDI
- Generic Name
- Manual blood lancing device, reusable FDA UDI
- Device Name
- Medical laser system EUDAMED
- Model / Reference
- LMT-1000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800031600086 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800031600086 EUDAMED
- 510(k) Number
- K172818 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
- GMDN Term
- Manual blood lancing device, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood lancet, single-use
HandyRay-Lite by Lameditech Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — 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
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800031600086 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Lameditech Co., Ltd.
- EUDAMED SRN
- KR-MF-000007869
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED cbd3e7ea-2ef0-4376-b06a-b25f59081bf4 61 fields · synced Jul 9, 2026
- FDA UDI 47fd620a-7aaf-4bc9-a054-f52402f627a7 34 fields · synced May 29, 2026