Identity
- Trade Name
- Hysterosalpingography Catheter EUDAMED
- Device Name
- Hysterosalpingography Catheter EUDAMED
- Model / Reference
- HC-HSG-O7 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00819374022972 EUDAMED
- Basic UDI-DI
- 081226101HSG052R6 EUDAMED
- Direct Marketing DI
- 00819374022972 EUDAMED
- EMDN Code
- U080102 CATHETERS FOR HYSTEROSALPINGOGRAPHY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
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
Hysterosalpingography Catheter by Allwin Medical Devices, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081226101HSG052R6 | Class I | Active |
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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 (2)
- EUDAMED fdacba26-00ab-4adf-9c02-0b9d85a55ca3 61 fields · synced Jun 20, 2026
- EUDAMED 0efac387-7a79-410e-986b-fca4e4a9559f 61 fields · synced Jun 20, 2026