Identity
- Trade Name
- Aveta Opal Reusable Cable EUDAMEDFDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- Aveta Opal Reusable Cable EUDAMEDAveta Opal Reusable Cable for use with Aveta Opal Disposable Hysteroscope, 4.6mm and Aveta System FDA UDI
- Model / Reference
- 220-2011 EUDAMEDFDA UDI
- Description
- Aveta Opal Reusable Cable for use with Aveta Opal Disposable Hysteroscope, 4.6mm and Aveta System FDA UDI
Identifiers
- Catalog Number
- 220-2011 FDA UDI
- Primary DI / UDI-DI
- 00850006759583 EUDAMEDFDA UDI
- Basic UDI-DI
- 00850006759583E4 EUDAMED
- Direct Marketing DI
- 00850006759583 EUDAMED
- 510(k) Number
- K190372 FDA UDI
- FDA Product Code
- HIH FDA UDIHIG FDA UDI
- EMDN Code
- L0317 GENERAL SURGERY ADAPTERS AND CONNECTORS, REUSABLE EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I 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
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
Aveta Opal Reusable Cable by Meditrina, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 00850006759583E4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Meditrina, Inc.
- EUDAMED SRN
- US-MF-000033191
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 916ba758-3a0b-45bc-af66-25dbf0a20aff 61 fields · synced Jul 29, 2026
- FDA UDI af5f84e8-235c-4e3b-a1ee-a2adda9f1fc3 35 fields · synced May 29, 2026