Identity
- Trade Name
- Aveta Fluid Management Accessory EUDAMEDFDA UDI
- Generic Name
- Surgical irrigation/aspiration tubing set FDA UDI
- Device Name
- Aveta Fluid Management Accessory EUDAMEDAveta Fluid Management Accessory for use with Aveta System FDA UDI
- Model / Reference
- 205-212 EUDAMEDFDA UDI
- Description
- Aveta Fluid Management Accessory for use with Aveta System FDA UDI
Identifiers
- Catalog Number
- 205-212 FDA UDI
- Primary DI / UDI-DI
- 00850006759231 EUDAMEDFDA UDI
- Basic UDI-DI
- 00850006759231D2 EUDAMED
- 510(k) Number
- K190372 FDA UDI
- FDA Product Code
- HIH FDA UDIHIG FDA UDI
- EMDN Code
- Z12080285 GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Surgical irrigation/aspiration tubing set 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
Aveta Fluid Management Accessory by Meditrina, Inc. — Class IIa — 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 | 00850006759231D2 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 fb3d2614-47ca-4172-952e-7b8cf3d5fd35 61 fields · synced May 30, 2026
- FDA UDI 4b20eac4-4d84-4106-98ad-8f7f5a36d59e 35 fields · synced May 30, 2026