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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

HALKF051V — Class I MDR by Alker medicale S.r.l.

MD Atlas
Alker medicale S.r.l.

EUDAMED last updated this device on Nov 28, 2022

HALKF051V

805127754HALKF8T

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Alker medicale S.r.l.
UDI-DI code: 08051277540517
Reference / catalog number: HALKF051V

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View device family (Basic UDI)

Manufacturer information

Organization name: Alker medicale S.r.l.
SRN: IT-MF-000030943
Manufacturer status: Active

Related devices

HALKF052V805127754HALKF8TOn the market HALKF047V805127754HALKF8TOn the market HALKF50V805127754HALKF8TOn 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

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

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08051277540517
Basic UDI-DI: 805127754HALKF8T
Reference / catalog number: HALKF051V
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: GHOTO tappo in silicone
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 330 MU03

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

Z12029011OPTICAL HEATERS

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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