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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

ED-1010 — Class I MDR by Telic, S.A.U.

MD Atlas
Telic, S.A.U.

EUDAMED last updated this device on Aug 20, 2024

ED-1010

8427734DFELECW/OCABLEADF2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Telic, S.A.U.
UDI-DI code: 08427734010853
Reference / catalog number: ED-1010

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Manufacturer information

Organization name: Telic, S.A.U.
SRN: ES-MF-000001853
Manufacturer status: Active

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Critical warnings

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

CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Spain; available across 1 country total.

Placed on the market in Spain; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 08427734010853
Basic UDI-DI: 8427734DFELECW/OCABLEADF2
Reference / catalog number: ED-1010
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Set of two adhesive pre-gelled pads with conductive hydrogel for defibrillation. To be used for adult patient use.
Additional information URL: https://www.telic.group/es/gsoft_ui/index/index/file/MUB20_20230220.pdf/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

C020480CARDIOVERSION AND EXTERNAL DEFIBRILLATION DEVICES - ACCESSORIES

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

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.