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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

HRT-005 — Class III MDD by BIOTECK S.p.A.

MD Atlas
BIOTECK S.p.A.

EUDAMED last updated this device on May 26, 2026

HRT-005

B-80565185093465A

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: BIOTECK S.p.A.
UDI-DI code: D-80565185093465A
Reference / catalog number: HRT-005

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View device family (Basic UDI)

Manufacturer information

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

Related devices

ACT-MLD050B-80565185022243AOn the market ACT-MLD020B-80565185022173DOn the market ACT-PTY010B-80565185022553MOn the market ACT-PTY030B-805651850227943On the market ACT-PTY050B-80565185022863YOn 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

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	Mar 17, 2008	Dec 31, 2027

Device identification

Trade name: not provided
UDI-DI code: D-80565185093465A
Basic UDI-DI: B-80565185093465A
Reference / catalog number: HRT-005
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: Pericardium membrane - 2 pc 20 x 20 x 0.2-0.4 mm
Additional information URL: https://bioteck.com/bhrt
Clinical sizes: 20 MU50
0.2–0.4 MU50
20 MU50

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.

P900401BONE AND TENDON REPLACEMENT DEVICES
P900402RESORBABLE FILLING AND RECONSTRUCTION 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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