Cook G44429
by William a. Cook Australia Pty. Ltd.
Ref K-MINC-2000
Cook G44429 (K-MINC-2000) is a device classified as Class IIa in the EU and Class II in the US made by William a. Cook Australia Pty. Ltd., registered in EUDAMED on 4 May 2026 (Basic UDI-DI B-00827002444294) and listed in FDA GUDID since 15 Aug 2023 (UDI-DI 00827002444294), active as of 23 Oct 2026.
Active
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-00827002444294 00827002444294 | Date4 May 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00827002444294 | Date15 Aug 2023 | StatusListed |
Official records
- EUDAMED public site B-00827002444294
- AccessGUDID record 00827002444294
Across registries
- EUDAMED Basic UDI-DI B-00827002444294 registered 4 May 2026 Active
- FDA GUDID UDI-DI 00827002444294 listed 15 Aug 2023 Listed
Timeline
- Listed FDA GUDID 00827002444294
- Registered EUDAMED B-00827002444294
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Minc+ EUDAMEDCook GUDID
- Generic name
- Assisted reproduction heater/incubator
- Model / Ref / Catalog
- K-MINC-2000, G44429
- Primary DI / UDI-DI
- 00827002444294
- Basic UDI-DI
- B-00827002444294
- FDA product code
- MQG
- EMDN code
- Z12080299 Gynaecology and fertility treatment instruments - other
- GMDN term
- Assisted reproduction heater/incubator
- Device class
- Class IIa EUDAMEDClass II GUDID
- Regulation number
- 884.6120
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / reference | K-MINC-2000 | G44429 |
| Device class | Class IIa | Class II |
| Supplied sterile | No | Yes |
Registry differences
EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:
- Supplied sterile UDI-DI 00827002444294: EUDAMED states No, FDA GUDID states Yes.
Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.
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