Identity
- Trade Name
- EZ-Grip FDA UDI
- Generic Name
- Assisted reproduction microtool FDA UDI
- Device Name
- EZ-Grip EUDAMEDAssisted Reproduction Microtools (Pipettes) FDA UDI
- Model / Reference
- EZ-Grip EUDAMEDEZ-Grip & Comfort Rest EUDAMEDWith Comfort Rest Denudation and Handling Pipettor FDA UDI
- Description
- Assisted Reproduction Microtools (Pipettes) FDA UDI
Identifiers
- Catalog Number
- 7-72-2802 FDA UDI
- Primary DI / UDI-DI
- 05060488047343 EUDAMEDFDA UDI
- Basic UDI-DI
- 506017018TD017UN EUDAMED
- 510(k) Number
- K161275 FDA UDI
- FDA Product Code
- MQH FDA UDI
- EMDN Code
- U0802030202 HANDPIECES FOR TIPS FOR ASSISTED REPRODUCTION EUDAMED
- GMDN Term
- Assisted reproduction microtool FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6130 FDA UDI
- Market of Registration
- Austria 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
EZ-Grip by CooperSurgical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 506017018TD017UN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
- EUDAMED SRN
- US-MF-000002607
- Authorised Representative
- CooperSurgical Distribution B.V. NL-AR-000000059
Sources (2)
- EUDAMED 4fc7eae9-0e47-42e5-b62e-13a1d4a66b7d 61 fields · synced Jul 25, 2026
- FDA UDI 9c2d2dde-fa1e-4d4f-b257-66c648233f1b 36 fields · synced May 29, 2026