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EZ-Strip

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 7-72-1155/20Ref 7-72-1200/20Ref 7-72-1135/20Ref 7-72-1600/20Ref 7-72-1145L/20Ref 7-72-1170/20

by CooperSurgical, Inc.

Identity

Trade Name
EZ-Strip EUDAMEDFDA UDI
Generic Name
Assisted reproduction microtool FDA UDI
Device Name
EZ-Range Pipettes EUDAMED
assisted Reproduction Microtools (Pipettes) FDA UDI
Model / Reference
7-72-1155/20 EUDAMED
7-72-1200/20 EUDAMED
7-72-1135/20 EUDAMED
7-72-1600/20 EUDAMED
7-72-1145L/20 EUDAMED
7-72-1170/20 EUDAMED
155µm FDA UDI
290µm FDA UDI
170µm FDA UDI
145µm Long FDA UDI
200µm FDA UDI
135µm FDA UDI
Description
assisted Reproduction Microtools (Pipettes) FDA UDI

Identifiers

Catalog Number
7-72-1170/20 FDA UDI
7-72-1600/20 FDA UDI
7-72-1145L/20 FDA UDI
7-72-1290/20 FDA UDI
7-72-1135/20 FDA UDI
Primary DI / UDI-DI
05060488046896 EUDAMEDFDA UDI
05060488046933 EUDAMEDFDA UDI
05060488046902 EUDAMEDFDA UDI
05060488046889 EUDAMEDFDA UDI
05060488046919 EUDAMEDFDA UDI
05060488046865 EUDAMEDFDA UDI
Basic UDI-DI
0888937TD051ZL EUDAMED
510(k) Number
K161275 FDA UDI
FDA Product Code
MQH FDA UDI
EMDN Code
U0802030201 TIPS FOR ASSISTED REPRODUCTION EUDAMED
GMDN Term
Assisted reproduction microtool FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
884.6130 FDA UDI
Market of Registration
Austria EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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 UDIFDA 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

Category: Assisted reproduction microtool

EZ-Strip by CooperSurgical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Assisted reproduction microtool.

Cleared under the same submission

K161275 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
CooperSurgical, Inc.

Sources (12)

  • FDA UDI 35295cba-a341-4a19-9860-d246e0aea031 35 fields · synced Sep 17, 2026
  • FDA UDI 726056be-e83e-4c02-b83f-9c48cad36545 35 fields · synced May 25, 2026
  • FDA UDI f94b881e-2fed-4b0b-b265-a26e550cfe3f 36 fields · synced May 30, 2026
  • FDA UDI 502129ab-efcd-4dd2-91a3-60f9d62af4ec 36 fields · synced May 30, 2026
  • FDA UDI bdcba70d-c97d-4c02-9c5e-2f9d852be66c 35 fields · synced May 30, 2026
  • FDA UDI af8a3a67-6abd-4428-98d7-14caa2846679 36 fields · synced May 30, 2026
  • EUDAMED 07634279-9a97-4013-a34f-5bbabd7cc675 61 fields · synced Jul 10, 2026
  • EUDAMED b095dc51-3d91-4b50-bc25-8825469ea3fb 61 fields · synced Jul 12, 2026
  • EUDAMED 871fdf00-72a3-40f8-9a59-01ae5764c2a8 61 fields · synced Jul 13, 2026
  • EUDAMED c2b5ca70-5fb1-4c88-b749-4ca8892f1722 61 fields · synced Jul 25, 2026
  • EUDAMED 68e909a8-9c9b-44cc-bb22-3bf77b788a36 61 fields · synced Jul 28, 2026
  • EUDAMED 9e71dc7e-8730-4a94-8509-2821dcfd080c 61 fields · synced Sep 17, 2026