Identity
- Trade Name
- Aveta Reusable Resecting Handset EUDAMEDFDA UDI
- Generic Name
- Tissue morcellation system control unit FDA UDI
- Device Name
- Aveta Reusable Resecting Handset EUDAMEDFDA UDI
- Model / Reference
- 211-001 EUDAMEDFDA UDI
- Description
- Aveta Reusable Resecting Handset FDA UDI
Identifiers
- Catalog Number
- 211-001 FDA UDI
- Primary DI / UDI-DI
- 00850006759040 EUDAMEDFDA UDI
- Basic UDI-DI
- 00850006759040CR EUDAMED
- Direct Marketing DI
- 00850006759040 EUDAMED
- 510(k) Number
- K190372 FDA UDI
- FDA Product Code
- HIH FDA UDIHIG FDA UDI
- EMDN Code
- Z12080204 MORCELLATORS EUDAMED
- GMDN Term
- Tissue morcellation system control unit 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
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
Moist Heat or Steam Sterilization FDA UDI
Aveta Reusable Resecting Handset 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 | 00850006759040CR | 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 c61cc730-80e3-4e5a-9ecd-eb33c1219c22 61 fields · synced Jun 18, 2026
- FDA UDI 7438c52a-e0c6-43c9-a99d-07503321636c 35 fields · synced May 30, 2026