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Aveta Coral Disposable Hysteroscope
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 214-251
Identity
- Trade Name
- Aveta Coral Disposable Hysteroscope EUDAMEDFDA UDI
- Generic Name
- Rigid video hysteroscope FDA UDI
- Device Name
- Aveta Coral Disposable Hysteroscope EUDAMEDAveta Coral Disposable Hysteroscope for use with Aveta System FDA UDI
- Model / Reference
- 214-251 EUDAMEDFDA UDI
- Description
- Aveta Coral Disposable Hysteroscope for use with Aveta System FDA UDI
Identifiers
- Catalog Number
- 214-251 FDA UDI
- Primary DI / UDI-DI
- 00850006759293 EUDAMEDFDA UDI
- Basic UDI-DI
- 00850006759293DQ EUDAMED
- 510(k) Number
- K190372 FDA UDI
- FDA Product Code
- HIH FDA UDIHIG FDA UDI
- EMDN Code
- Z12020704 HYSTEROSCOPES EUDAMED
- GMDN Term
- Rigid video hysteroscope FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1690 FDA UDI884.1700 FDA UDI
- Market of Registration
- Denmark 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rigid video hysteroscope
Aveta Coral Disposable Hysteroscope by Meditrina, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Rigid video hysteroscope.
- EndoMed Systems GmbH — EndoMed Systems GmbH · Class IIa
- HTx Jednorazowy Histeroskop — Suzhou AcuVu Medical Technology Co., Ltd. · Class IIa
- Hysteroscope — Innoview GmbH · Class IIa
- EndoMed Systems GmbH — EndoMed Systems GmbH · Class IIa
- HYSTEROSCOPE — Henke-Sass, Wolf 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
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192100 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 00850006759293DQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Meditrina, Inc.
- EUDAMED SRN
- US-MF-000033191
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED d6fe8c79-6ea6-4c4b-b995-8c77eee40ef2 61 fields · synced Jul 11, 2026
- FDA UDI 8ca0ddb5-85e4-4e20-8a03-f7f6979ca9a1 35 fields · synced May 29, 2026
- FDA 510(k) K192100 1 fields · synced May 18, 2026