Identity
- Trade Name
- Miris Cleaner™ FDA UDI
- Generic Name
- Wash/cleaning solution IVD, manual equipment FDA UDI
- Device Name
- Cleaning solution for Miris Human Milk Analyzer™. Concentrate, 50 mL. Dilute the content with 950 mL distilled or deionized water and mix. Warm to 35-40°C before use. FDA UDI
- Model / Reference
- 39-04-001 FDA UDI
- Description
- Cleaning solution for Miris Human Milk Analyzer™. Concentrate, 50 mL. Dilute the content with 950 mL distilled or deionized water and mix. Warm to 35-40°C before use. FDA UDI
Identifiers
- Catalog Number
- 39-04-001 FDA UDI
- Primary DI / UDI-DI
- 07350107530034 FDA UDI
- 510(k) Number
- DEN180007 FDA UDI
- FDA Product Code
- QEI FDA UDI
- GMDN Term
- Wash/cleaning solution IVD, manual equipment FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1493 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 50 Milliliter FDA UDI
Category: Wash/cleaning solution IVD, manual equipment
Miris Cleaner™ by Miris AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wash/cleaning solution IVD, manual equipment.
Cleared under the same submission
DEN180007 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
- Miris AB
Sources (1)
- FDA UDI 02a8a3cc-e121-4a98-8995-439e46cd51ef 38 fields · synced Jun 1, 2026