Identity
- Trade Name
- Hysterosalpingography Catheter EUDAMEDHYSTERO CATH FDA UDI
- Generic Name
- Intrauterine imaging medium catheter FDA UDI
- Device Name
- Hysterosalpingography Catheter EUDAMEDHYSTERO CATH Hysterosalpingography Catheter Closed Tip FDA UDI
- Model / Reference
- HC-HSG7 EUDAMEDHYSTERO CATH Hysterosalpingography Catheter Closed Tip FDA UDI
- Description
- HYSTERO CATH Hysterosalpingography Catheter Closed Tip FDA UDI
Identifiers
- Catalog Number
- HC-HSG7 FDA UDI
- Primary DI / UDI-DI
- 00812261016689 EUDAMEDFDA UDI
- Basic UDI-DI
- 081226101HSG052R6 EUDAMED
- Direct Marketing DI
- 00812261016689 EUDAMED
- FDA Product Code
- LKF FDA UDI
- EMDN Code
- U080102 CATHETERS FOR HYSTEROSALPINGOGRAPHY EUDAMED
- GMDN Term
- Intrauterine imaging medium catheter FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Market of Registration
- Poland 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
Yes
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
No
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
Hysterosalpingography Catheter by Allwin Medical Devices, 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 | 081226101HSG052R6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Allwin Medical Devices, Inc
- EUDAMED SRN
- US-MF-000011349
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (3)
- EUDAMED 5c3b20ca-da3a-452f-870d-2391d1275aff 61 fields · synced Jun 18, 2026
- FDA UDI 4f8fdb7f-9f83-4395-b2e4-a93f949b36ef 35 fields · synced May 29, 2026
- EUDAMED 97d1ac86-5315-42d7-a7ff-8f1d6c935c15 61 fields · synced Jun 18, 2026