Identity
- Trade Name
- HemoCue® Glucose 201 DM Analyzer FDA UDI
- Generic Name
- Glucose monitoring system IVD, point-of-care FDA UDI
- Device Name
- HemoCue Glucose 201 DM Analyzer mmol/L plasma FDA UDI
- Model / Reference
- 121444 FDA UDI
- Description
- HemoCue Glucose 201 DM Analyzer mmol/L plasma FDA UDI
Identifiers
- Catalog Number
- 121444 FDA UDI
- Primary DI / UDI-DI
- 07311091214447 FDA UDI
- 510(k) Number
- K041230 FDA UDI
- FDA Product Code
- LFR FDA UDI
- GMDN Term
- Glucose monitoring system IVD, point-of-care 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
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
No
FDA UDI
Category: Glucose monitoring system IVD, point-of-care
HemoCue® Glucose 201 DM Analyzer by Hemocue, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K041230 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 |
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Manufacturer
- Manufacturer
- Hemocue, Inc.
Sources (1)
- FDA UDI 7756ebf1-3af7-40f9-9940-a68b04599ab7 36 fields · synced Jun 1, 2026