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Aveta Flex Disposable Resecting Tip, 2.9 mm

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 204-210

by Meditrina, Inc.

Identity

Trade Name
Aveta Flex Disposable Resecting Tip, 2.9 mm EUDAMED
Aveta Smol Disposable Resecting Device, 2.9 mm FDA UDI
Generic Name
Tissue morcellation system handpiece, line-powered FDA UDI
Device Name
Aveta Flex Disposable Resecting Tip, 2.9 mm EUDAMED
Aveta Flex Disposable Resecting Tip, 2.9 mm, for use with Aveta System FDA UDI
Model / Reference
204-210 EUDAMEDFDA UDI
Description
Aveta Flex Disposable Resecting Tip, 2.9 mm, for use with Aveta System FDA UDI

Identifiers

Catalog Number
204-210 FDA UDI
Primary DI / UDI-DI
00850006759484 EUDAMEDFDA UDI
Basic UDI-DI
00850006759484DZ EUDAMED
510(k) Number
K190372 FDA UDI
FDA Product Code
HIG FDA UDI
HIH FDA UDI
EMDN Code
Z12080204 MORCELLATORS EUDAMED
GMDN Term
Tissue morcellation system handpiece, line-powered FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
884.1700 FDA UDI
884.1690 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 Flex 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

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Manufacturer

Manufacturer
Meditrina, Inc.
EUDAMED SRN
US-MF-000033191
Authorised Representative
Advena Limited MT-AR-000000234

Sources (2)

  • EUDAMED 956f20a3-9034-45ba-bc63-26f6b0a9e3cf 61 fields · synced Jun 19, 2026
  • FDA UDI 997e5024-2890-46d2-b45d-179cd28a3b44 35 fields · synced May 30, 2026