EUDAMED last updated this device on Jul 3, 2026

Ultrasonic Soft Tissue Cutting and Sealing System

B-06933816803753

On the marketClass IIb

Applicable legislation: —
Organization name: Suzhou Frankenman Medical Equipment Co.,Ltd
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 06933816803753
Reference / catalog number: FU-01M

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

Ultrasonic Soft Tissue Cutting and Sealing System is an EU-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Suzhou Frankenman Medical Equipment Co.,Ltd. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: Ultrasonic Soft Tissue Cutting and Sealing System
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 06933816803753
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: B-06933816803753
Reference / catalog number: FU-01M
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: Class IIb
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06933816803753

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

K020299DEVICES FOR SURGERY WITH ULTRASONIC GENERATOR, SINGLE-USE - OTHER

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

Consult instructions for use

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Germany; available across 8 countries total.

Country	On market since	Until
GermanyPrimary placement	—	Still on market
Austria	—	Still on market
Denmark	—	Still on market
Spain	—	Still on market
France	—	Still on market
Italy	—	Still on market
Latvia	—	Still on market
Poland	—	Still on market

Related searches

Class IIb medical devices in EUDAMED

Device identification

Trade name: Ultrasonic Soft Tissue Cutting and Sealing System
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 06933816803753
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: B-06933816803753
Reference / catalog number: FU-01M
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Germany; available across 8 countries total.

Country	On market since	Until
GermanyPrimary placement	—	Still on market
Austria	—	Still on market
Denmark	—	Still on market
Spain	—	Still on market
France	—	Still on market
Italy	—	Still on market
Latvia	—	Still on market
Poland	—	Still on market

Ultrasonic Soft Tissue Cutting and Sealing System

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Legacy certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates covering this device

Legacy certificates

Certificates

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