Identity
- Trade Name
- Aveta Waste Bag (with Cap) EUDAMEDAveta Waste Bag FDA UDI
- Generic Name
- Surgical tissue/fluid collection bag, non-sterile FDA UDI
- Device Name
- Aveta Waste Bag (with Cap) EUDAMEDAveta Waste Bag (with cap), for use with Aveta System FDA UDI
- Model / Reference
- 205-2000 EUDAMEDFDA UDI
- Description
- Aveta Waste Bag (with cap), for use with Aveta System FDA UDI
Identifiers
- Catalog Number
- 205-2000 FDA UDI
- Primary DI / UDI-DI
- 00850006759361 EUDAMEDFDA UDI
- Basic UDI-DI
- 00850006759361DG 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 tissue/fluid collection bag, non-sterile 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
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 Waste Bag (with Cap) 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 | 00850006759361DG | 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 63b101e0-1549-476f-9a6a-ce6a4eed83b6 61 fields · synced Jun 18, 2026
- FDA UDI f63d0c4a-4024-403b-aeb3-0f7f0cbced35 35 fields · synced May 30, 2026