Identity
- Trade Name
- MINC+ Benchtop Incubator EUDAMEDCOOK FDA UDI
- Generic Name
- Assisted reproduction heater/incubator FDA UDI
- Device Name
- MINC+ Benchtop Incubator EUDAMEDFDA UDI
- Model / Reference
- K-MINC-2000 EUDAMEDG44429 FDA UDI
- Description
- MINC+ Benchtop Incubator FDA UDI
Identifiers
- Catalog Number
- K-MINC-2000 FDA UDI
- Primary DI / UDI-DI
- 00827002444294 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00827002444294 EUDAMED
- FDA Product Code
- MQG FDA UDI
- EMDN Code
- Z12080299 GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Assisted reproduction heater/incubator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6120 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Assisted reproduction heater/incubator
Cook by William A. Cook Australia Pty. Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- William A. Cook Australia Pty. Ltd.
Sources (2)
- FDA UDI 82405d47-95bd-40ba-96e1-0969c4d7beb8 36 fields · synced Jul 17, 2026
- EUDAMED fda7cf84-e215-4ef2-bf96-e0813affe4cb 61 fields · synced Jul 17, 2026