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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

H8009 — Class I MDR by Sabatini Calzature S.r.l.

MD Atlas
Sabatini Calzature S.r.l.

EUDAMED last updated this device on Jun 7, 2024

H8009

805574862HALNJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sabatini Calzature S.r.l.
UDI-DI code: 08055748620173
Reference / catalog number: H8009

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View device family (Basic UDI)

Manufacturer information

Organization name: Sabatini Calzature S.r.l.
SRN: IT-MF-000038906
Manufacturer status: Active

Related devices

H3205D805574862BOSPCOn the market B0003805574862BOSPCOn the market H0001805574862REHQ8On the market H0002805574862REHQ8On the market H0003805574862REHQ8On 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: 08055748620173
Basic UDI-DI: 805574862HALNJ
Reference / catalog number: H8009
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: SCARPA ORTOPEDICA DONNA SU FONDO IN MICRO CON TOMAIA ELASTICIZZATA
Additional information URL: https://www.hergos.it/
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)08055748620173

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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.

Y063303READY-MADE ORTHOTIC SHOES

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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