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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

TR04 — Class IIb MDD by PROMECHI, S.L.

MD Atlas
PROMECHI, S.L.

EUDAMED last updated this device on Apr 2, 2025

TR04

B-08435245311048

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: PROMECHI, S.L.
UDI-DI code: 08435245311048
Reference / catalog number: TR04

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Manufacturer information

Organization name: PROMECHI, S.L.
SRN: ES-MF-000010973
Manufacturer status: Active

Related devices

TR05B-08435245311055On the market SL05B-08435245311154On the market SL06B-08435245311161On the market SL07B-08435245311178On the market SL08B-08435245311185On the market

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	Jan 25, 2000	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08435245311048
Basic UDI-DI: B-08435245311048
Reference / catalog number: TR04
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: CANULA DE TRAQUEOTOMIA DE PLATA Nº 4 - 10x68 mm
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

R010599TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - OTHER

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.