Identity
- Trade Name
- Adjustable Handle Set EUDAMEDFlexipet FDA UDI
- Generic Name
- Mechanical pipette FDA UDI
- Device Name
- Flexipet® EUDAMEDFlexipet, Adjustable Handle Set FDA UDI
- Model / Reference
- K-MPH-1000 EUDAMEDG18674 FDA UDI
- Description
- Flexipet, Adjustable Handle Set FDA UDI
Identifiers
- Catalog Number
- K-MPH-1000 FDA UDI
- Primary DI / UDI-DI
- 00827002186743 EUDAMEDFDA UDI
- Basic UDI-DI
- 0827002CINC090-063_ALY EUDAMED
- FDA Product Code
- MQJ FDA UDI
- EMDN Code
- U080299 DEVICES FOR ASSISTED REPRODUCTION - OTHER EUDAMED
- GMDN Term
- Mechanical pipette FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6150 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Assisted reproduction vitrification carrier
Adjustable Handle Set by Cook Incorporated — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0827002CINC090-063_ALY | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cook Incorporated
- EUDAMED SRN
- US-MF-000003180
- Authorised Representative
- COOK MEDICAL EUROPE LIMITED IE-AR-000000907
Sources (2)
- EUDAMED 2f596412-c2f3-48c6-a1e0-86363432c451 61 fields · synced Jun 19, 2026
- FDA UDI 7e2759bf-74a5-44eb-a8ca-aeead29b5375 36 fields · synced May 30, 2026