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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

FB H4a — Class IIa MDR by SANADEN SRLS

MD Atlas
SANADEN SRLS

EUDAMED last updated this device on May 13, 2026

FB H4a

80517066316T

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SANADEN SRLS
UDI-DI code: 08051706631052
Reference / catalog number: FB H4a

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View device family (Basic UDI)

Manufacturer information

Organization name: SANADEN SRLS
SRN: IT-MF-000035916
Manufacturer status: Active

Related devices

FB H2a 80517066316TOn the market FB H3c80517066316TOn the market FB H3a80517066316TOn the market FB H4c80517066316TOn the market FB H2c80517066316TOn 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.

Country	On market since	Until
ItalyPrimary placement	Apr 4, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08051706631052
Basic UDI-DI: 80517066316T
Reference / catalog number: FB H4a
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Ribbon for reinforcement - UHMW PE
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 26 MU10
4 MU50

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08051706631052

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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.

Q010199CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - 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

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