Identity
- Trade Name
- GyneCath® Catheter EUDAMEDGyneCath Catheter • 5F FDA UDI
- Generic Name
- Salpingographic catheter FDA UDI
- Device Name
- H/S Catheter w/Balloon EUDAMEDGyneCath Catheter • 5F for Hysterosonography and Hysterosalpingography FDA UDI
- Model / Reference
- 61-5005 EUDAMED19610 EUDAMEDFDA UDI
- Description
- GyneCath Catheter • 5F for Hysterosonography and Hysterosalpingography FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937016550 EUDAMEDFDA UDI
- Basic UDI-DI
- 0888937TD064ZV EUDAMED
- 510(k) Number
- K961752 FDA UDI
- FDA Product Code
- LKF FDA UDI
- EMDN Code
- U080102 CATHETERS FOR HYSTEROSALPINGOGRAPHY EUDAMED
- GMDN Term
- Salpingographic catheter FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Market of Registration
- Netherlands 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
Yes
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
GyneCath® Catheter 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 | 0888937TD064ZV | 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 b9ff117f-c2ef-414b-8282-f97c6ff1a24d 61 fields · synced Jul 24, 2026
- FDA UDI c0371261-4bc8-48f8-9b69-bbb464fe8a4b 34 fields · synced May 30, 2026