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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

10100.401 — Class IIb MDR by LED SpA

MD Atlas
LED SpA

EUDAMED last updated this device on Mar 10, 2026

10100.401

803363832HFS00144

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: LED SpA
UDI-DI code: 08033638321140
Reference / catalog number: 10100.401

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View device family (Basic UDI)

Manufacturer information

Organization name: LED SpA
SRN: IT-MF-000012232
Manufacturer status: Active

Related devices

70500.10/10803363832ECS001ZROn the market 70500.10/20803363832ECS001ZROn the market CRB001803363832ECS001ZROn the market 80500.10803363832STE002ADOn the market APM10900.201803363832HFS00144On 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.

CW011
EUDAMED did not publish a description for this code.
CW017
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 3 countries total.

Country	On market since	Until
ItalyPrimary placement		Still on market
Ireland		Still on market
Malta		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08033638321140
Basic UDI-DI: 803363832HFS00144
Reference / catalog number: 10100.401
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: The SURTRON 200 is a versatile electrosurgical device designed to deliver currents suitable for cutting, coagulated shear and coagulation in monopolar mode, as well as coagulation in bipolar mode.
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)08033638321140

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

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

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