Synergo® System

Organization name

Medical Enterprises Europe B.V.

SRN

NL-MF-000019133

Manufacturer status

Active

4 warnings recorded — scroll inside the panel to see all entries.

• CW011

  The caution contains important information about patient or user safety. Failure to follow these instructions could lead to minor adverse effects on the health and safety of patients and users.
• CW010

  EUDAMED did not publish a description for this code.
• CW273

  EUDAMED did not publish a description for this code.
• CW999

  non-ionising radiation emission:RF Generator -915 MHz (+ 50 KHz)

Primary placement in Netherlands; available across 5 countries total.

Trade name

Synergo® System

UDI-DI code

07290010121045

Basic UDI-DI

B-07290010121045

Reference / catalog number

SB-TS 101.3

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Synergo Technology , The Radiofrequency-Induced Thermo-Chemotherapy Effect (RITE) : RF device for delivery of chemotherapy under hyperthermia (RF-Induced Thermochemotherapy)

Additional information URL

http://www.synergo-medical.com/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• Z12169080VARIOUS INSTRUMENTS FOR UROLOGY - HARDWARE ACCESSORIES