Identity
- Trade Name
- HemoCue® Hb 201 DM Analyzer FDA UDI
- Generic Name
- Haemoglobin analyser IVD, point-of-care FDA UDI
- Device Name
- HemoCue Hb 201 DM Analyzer g/dL FDA UDI
- Model / Reference
- 121135 FDA UDI
- Description
- HemoCue Hb 201 DM Analyzer g/dL FDA UDI
Identifiers
- Catalog Number
- 121135 FDA UDI
- Primary DI / UDI-DI
- 07311091211354 FDA UDI
- 510(k) Number
- K041234 FDA UDI
- FDA Product Code
- GKR FDA UDI
- GMDN Term
- Haemoglobin analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5620 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: Haemoglobin analyser IVD, point-of-care
HemoCue® Hb 201 DM Analyzer by Hemocue, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemoglobin analyser IVD, point-of-care.
- DiaSpect Tm — EKF-diagnostic GmbH · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Add Pack Hemo Control DM — EKF-diagnostic GmbH · Class II
- DiaSpect Tm — EKF-diagnostic GmbH · Class II
- Mission Plus Hemoglobin (Hb) Monitoring System — ACON Laboratories, Inc. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
Cleared under the same submission
K041234 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 a2bb5176-fbe7-4831-9212-d8b8d2462323 36 fields · synced Jun 1, 2026