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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

KENTAMED ACTIS-400 — Class IIb MDR by KENTAMED Ltd.

MD Atlas
KENTAMED Ltd.

EUDAMED last updated this device on Jul 25, 2022

KENTAMED ACTIS-400

3800943ACTIS400P4

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: KENTAMED Ltd.
UDI-DI code: 03800943000153
Reference / catalog number: 10-11-05

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Manufacturer information

Organization name: KENTAMED Ltd.
SRN: BG-MF-000022619
Manufacturer status: Active

Related devices

KENTAMED ACTIS-1503800943ACTIS150P4On the market KENTAMED ACTIS-150a3800943ACTIS150P4On the market KENTAMED RF-1203800943RF120NJOn the market KENTAMED RF-120a3800943RF120NJOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

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

CW274
EUDAMED did not publish a description for this code.
CW014
EUDAMED did not publish a description for this code.
CW011
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Bulgaria; available across 1 country total.

Country	On market since	Until
BulgariaPrimary placement	Apr 3, 2023	Still on market

Device identification

Trade name: KENTAMED ACTIS-400
UDI-DI code: 03800943000153
Basic UDI-DI: 3800943ACTIS400P4
Reference / catalog number: 10-11-05
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
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.

EMDN nomenclature code(s)

Z12010902ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification