Blueendo

FDA UDI

Class II (US FDA UDI)

by TROKAMED GmbH

Identity

Trade Name: BLUEENDO FDA UDI
Generic Name: Tissue morcellation system FDA UDI
Device Name: Flexible Shaft, WL 2,5 m FDA UDI
Model / Reference: 02-33041 FDA UDI
Description: Flexible Shaft, WL 2,5 m FDA UDI

Identifiers

Catalog Number: 02-33041 FDA UDI
Primary DI / UDI-DI: 04251303811367 FDA UDI
FDA Product Code: HET FDA UDI
GMDN Term: Tissue morcellation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1720 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Tissue morcellation system

Blueendo by TROKAMED GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Tissue morcellation system.

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MultiCut Blade 400 — Asclepion Laser Technologies GmbH · Class II
Versacut Tissue Morcellator — Lumenis · Class II
Versacut™ — Lumenis · Class II
TruClear — Covidien LP · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: TROKAMED GmbH

Sources (1)

FDA UDI f679f88a-d959-4484-b548-fea724cfa841 35 fields · synced Jun 7, 2026