Identity
- Trade Name
- Gochek2 FDA UDI
- Generic Name
- Glucose analyser IVD, home-use FDA UDI
- Device Name
- Blood Glucose Meter FDA UDI
- Model / Reference
- 1017+ FDA UDI
- Description
- Blood Glucose Meter FDA UDI
Identifiers
- Catalog Number
- 1017+-PMTL-007 FDA UDI
- Primary DI / UDI-DI
- 06958590302520 FDA UDI
- 510(k) Number
- K193340 FDA UDI
- FDA Product Code
- NBW FDA UDI
- GMDN Term
- Glucose analyser IVD, home-use 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
No
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
Category: Glucose analyser IVD, home-use
Gochek2 by Microtech Medical (Hangzhou) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glucose analyser IVD, home-use.
- Accu-Chek Guide — Roche Diagnostics Operations, Inc. · Class II
- MIO / TeleRPM — Mio Labs Inc. · Class II
- CURO L5 — KPI HEALTHCARE, INC. · Class II
- OneTouch Verio Flex — Lifescan Europe · Class II
- telli health — Bioland Technology Ltd. · Class II
- OneTouch Ultra2 — Lifescan Europe · Class II
- iHealth — IHEALTH LAB INC. · Class II
- NuvoMed — NUVOMED INC · Class II
Cleared under the same submission
K193340 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Microtech Medical (Hangzhou) Co., Ltd.
Sources (1)
- FDA UDI 1e0218f3-9216-440b-bf57-beaa04174d53 35 fields · synced May 30, 2026