Identity
- Trade Name
- telli health FDA UDI
- Generic Name
- Manual blood lancing device, reusable FDA UDI
- Device Name
- Blood Glucose Monitoring System, It contains blood glucose meter, blood glucose test strips, lancing device and sterile lancet. FDA UDI
- Model / Reference
- G-427B FDA UDI
- Description
- Blood Glucose Monitoring System, It contains blood glucose meter, blood glucose test strips, lancing device and sterile lancet. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06939184630212 FDA UDI
- FDA Product Code
- NBW FDA UDI
- GMDN Term
- Manual blood lancing device, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Glucose monitoring system IVD, home-useManual blood lancing device, reusable
telli health by Bioland Technology Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual blood lancing device, reusable.
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- Autolet — OWEN MUMFORD USA INCORPORATED · Class II
- Lancing Device — Shandong Lianfa Medical Plastic Products CO., LTD · Class II
- TeleRPM & Chronica — Mio Labs Inc.
- Accu-Chek Safe-T-Pro — ROCHE DIABETES CARE, INC. · Class II
- Accu-Chek Fastclix — ROCHE DIABETES CARE, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bioland Technology Ltd.
Sources (1)
- FDA UDI 5e3f7c79-3659-4a8e-bcc7-f2a5fd11d7d7 33 fields · synced Jun 1, 2026