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Aveta Smol Disposable Resecting Tip, 2.9 mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 204-239
Identity
- Trade Name
- Aveta Smol Disposable Resecting Tip, 2.9 mm EUDAMEDAveta Smol Disposable Resecting Device, 2.9 mm FDA UDI
- Generic Name
- Tissue morcellation system handpiece, line-powered FDA UDI
- Device Name
- Aveta Smol Disposable Resecting Tip, 2.9 mm EUDAMEDAveta Smol Disposable Resecting Tip, 2.9 mm, for use with Aveta System FDA UDI
- Model / Reference
- 204-239 EUDAMEDFDA UDI
- Description
- Aveta Smol Disposable Resecting Tip, 2.9 mm, for use with Aveta System FDA UDI
Identifiers
- Catalog Number
- 204-239 FDA UDI
- Primary DI / UDI-DI
- 00850006759460 EUDAMEDFDA UDI
- Basic UDI-DI
- 00850006759460DK EUDAMED
- 510(k) Number
- K190372 FDA UDI
- FDA Product Code
- HIG FDA UDIHIH FDA UDI
- EMDN Code
- Z12080204 MORCELLATORS EUDAMED
- GMDN Term
- Tissue morcellation system handpiece, line-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1700 FDA UDI884.1690 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
Yes
FDA UDI
Aveta Smol Disposable Resecting Tip, 2.9 mm 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 | 00850006759460DK | 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 8ad9e443-b048-4ccc-a747-f4f1c8f41fc9 61 fields · synced Jun 18, 2026
- FDA UDI 555083c6-bd99-44ea-a2a7-a04d7546e38e 35 fields · synced May 29, 2026