Identity
- Trade Name
- HYSTEROSCOPE EUDAMEDHYST 2,9/30/300 AK HD COVIDIEN FDA UDI
- Generic Name
- Rigid optical hysteroscope FDA UDI
- Device Name
- Hysteroscope EUDAMED
- Model / Reference
- 8300057945 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 8300057945 FDA UDI
- Primary DI / UDI-DI
- 04035873071419 EUDAMEDFDA UDI
- Basic UDI-DI
- 4035873120101059Y EUDAMED
- Direct Marketing DI
- 04035873071419 EUDAMED
- FDA Product Code
- HIH FDA UDI
- EMDN Code
- Z12020704 HYSTEROSCOPES EUDAMED
- GMDN Term
- Rigid optical hysteroscope FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1690 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 2.9 Millimeter FDA UDI
Category: Rigid video hysteroscope
Hysteroscope by Henke-Sass, Wolf GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid video hysteroscope.
- EndoMed Systems GmbH — EndoMed Systems GmbH · Class IIa
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- Hysteroscope — Innoview GmbH · Class IIa
- EndoMed Systems GmbH — EndoMed Systems GmbH · Class IIa
- Hys. 027.00.3020a 40k — Blazejewski MEDI-TECH GmbH · Class IIa
- Single-use Digital Hysteroscope — Zhejiang Geyi Medical Instrument Co., Ltd. · Class IIa
- Histeroscópio Descartável HTx — Suzhou AcuVu Medical Technology Co., Ltd. · Class IIa
- Hystéroscope à Usage Unique HTx — Suzhou AcuVu Medical Technology Co., Ltd. · Class IIa
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 | 4035873120101059Y | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Henke-Sass, Wolf GmbH
- EUDAMED SRN
- DE-MF-000005531
Sources (2)
- EUDAMED ccd82555-6b5f-458f-9078-6f57891b4cb7 61 fields · synced May 30, 2026
- FDA UDI 00960c25-6b4f-43c2-8b1e-8aa6ab6e0f6d 34 fields · synced May 29, 2026