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Organization name
UDI-DI code
Reference / catalog number

eD-AS Anaesthesia System — Class IIb MDR by TEMEL S.A.

MD Atlas
TEMEL S.A.

Manufacturer information

Organization name: TEMEL S.A.
SRN: ES-MF-000001321
Manufacturer status: Active

Related devices

This device is not currently linked to any other device.

EUDAMED last updated this device on May 15, 2024

eD-AS Anaesthesia System

843702170501BX

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: TEMEL S.A.
UDI-DI code: 08437021705010
Reference / catalog number: eD-AS

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Manufacturer information

Organization name: TEMEL S.A.
SRN: ES-MF-000001321
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Sep 21, 2016	Still on market

Device identification

Trade name: eD-AS Anaesthesia System
UDI-DI code: 08437021705010
Basic UDI-DI: 843702170501BX
Reference / catalog number: eD-AS
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 Sistema de Anestesia eD-AS is a device for use in the administration of inhalation anaesthesia and/or automatic, manual and spontaneous ventilation of patients (adults, children and neonates), with total or limited inability to breathe during anaesthesia.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z1203010101ANAESTHESIA DEVICES

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

Related devices

This device is not currently linked to any other device.