Aveta Pearl Disposable Hysteroscope
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Aveta Pearl Disposable Hysteroscope EUDAMEDFDA UDI
- Generic Name
- Rigid video hysteroscope FDA UDI
- Device Name
- Aveta Pearl Disposable Hysteroscope EUDAMEDAveta Pearl Disposable Hysteroscope for use with Aveta System FDA UDI
- Model / Reference
- 214-228 EUDAMEDFDA UDI
- Description
- Aveta Pearl Disposable Hysteroscope for use with Aveta System FDA UDI
Identifiers
- Catalog Number
- 214-228 FDA UDI
- Primary DI / UDI-DI
- 00850006759262 EUDAMEDFDA UDI
- Basic UDI-DI
- 00850006759262DD 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Rigid video hysteroscope
Aveta Pearl Disposable Hysteroscope by Meditrina, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
Cleared under the same submission
K190372 also covers:
- Aveta Coral Disposable Hysteroscope — Meditrina, Inc.
- Aveta Disposable Resecting Device 2.9 mm — Meditrina, Inc.
- Aveta Disposable Resecting Device 3.9 mm — Meditrina, Inc.
- Aveta Disposable Resecting Handset — Meditrina, Inc.
- Aveta Disposable Resecting Handset — Meditrina, Inc.
- Aveta Fluid Management Accessory — Meditrina, Inc.
- Aveta Max Disposable Resecting Device, 3.9 mm — Meditrina, Inc.
- Aveta Pearl Disposable Hysteroscope — Meditrina, Inc.
- Aveta Tissue Catch — Meditrina, Inc.
- Aveta Tissue Catch with Suction Tubing — Meditrina, Inc.
- Aveta Waste Bag with Tissue Catch — Meditrina, Inc.
- Aveta Waste Bag. 6L — Meditrina, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Meditrina, Inc.
Sources (2)
- FDA UDI 8b3c44f5-3366-4671-98e5-9a6c83cbcab8 35 fields · synced Jul 29, 2026
- EUDAMED 5316d07b-5675-431f-910a-246b14e50304 61 fields · synced Jul 29, 2026