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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

H42-304 — Class III MDD by BIOTECK S.p.A.

MD Atlas
BIOTECK S.p.A.

EUDAMED last updated this device on May 26, 2026

H42-304

B-80565185004283E

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: BIOTECK S.p.A.
UDI-DI code: D-80565185004283E
Reference / catalog number: H42-304

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View device family (Basic UDI)

Manufacturer information

Organization name: BIOTECK S.p.A.
SRN: IT-MF-000011484
Manufacturer status: Active

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Critical warnings

8 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW267
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.
CW129
COLLAGEN
CW161
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	Nov 23, 2020	Dec 31, 2027

Device identification

Trade name: not provided
UDI-DI code: D-80565185004283E
Basic UDI-DI: B-80565185004283E
Reference / catalog number: H42-304
Issuing entity: EUDAMED

Classification

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

Device details

Quantity: 1
Additional product description: Hydrogel Oral - 3 syr 0.4 cc/syr
Additional information URL: https://bioteck.com/bh42
Clinical sizes: 0.4 MU12

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.

P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES
P900401BONE AND TENDON REPLACEMENT DEVICES

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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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.