← Back to catalogue
H/S Elliptoshere™ Catheter
EUDAMEDFDA UDIClass I (EU MDR)
Ref 61-4005SModel 61-5005
Identity
- Trade Name
- H/S Elliptoshere™ Catheter EUDAMEDH/S Elliptosphere™ Catheter with Integrated Stylet FDA UDI
- Generic Name
- Salpingographic catheter FDA UDI
- Device Name
- H/S Catheter w/Balloon EUDAMEDH/S Elliptosphere™ Catheter with Integrated Stylet for Hysterosonography and Hysterosalpingography FDA UDI
- Model / Reference
- 61-5005 EUDAMED61-4005S EUDAMEDFDA UDI
- Description
- H/S Elliptosphere™ Catheter with Integrated Stylet for Hysterosonography and Hysterosalpingography FDA UDI
Identifiers
- Primary DI / UDI-DI
- 60888937016453 EUDAMEDFDA UDI
- Basic UDI-DI
- 0888937TD064ZV EUDAMED
- 510(k) Number
- K013972 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
Yes
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
H/S Elliptoshere™ 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CooperSurgical, Inc.
- EUDAMED SRN
- US-MF-000002607
- Authorised Representative
- CooperSurgical Distribution B.V. NL-AR-000000059
Sources (2)
- EUDAMED 627cf779-ab7e-4f1c-81e6-eef0884aea63 61 fields · synced Jul 15, 2026
- FDA UDI 28c1fab6-610c-40f0-917f-decc33a898b6 34 fields · synced May 30, 2026