Identity
- Trade Name
- HYSTEROFLATOR FDA UDI
- Generic Name
- Hysteroscopic insufflator FDA UDI
- Device Name
- HAMOU Micro-Hysteroflator FDA UDI
- Model / Reference
- 26431520-1 FDA UDI
- Description
- HAMOU Micro-Hysteroflator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048551069134 FDA UDI
- FDA Product Code
- HIG FDA UDI
- GMDN Term
- Hysteroscopic insufflator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hysteroscopic insufflator
Hysteroflator by Karl Storz GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hysteroscopic insufflator.
- DOLPHIN II — Gyrus Acmi, Inc. · Class II
- Gyrus ACMI — Gyrus Acmi, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Karl Storz GmbH & Co. KG
Sources (1)
- FDA UDI 4cc6640b-b56c-4ad1-9694-c8807ef56b05 33 fields · synced Jun 6, 2026