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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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HEART® Pericardium membrane — 1 UDI-DI variant, MDD (BIOTECK S.p.A.)

MD Atlas
BIOTECK S.p.A.

Data from EUDAMED, last updated May 30, 2026

HEART® Pericardium membrane

B-80565185093465A

1 UDI-DI variant

MDD [Directive 93/42/EEC on medical devices]Class III

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class III
Manufacturer: BIOTECK S.p.A.

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Device characteristics

ImplantableAnimal tissues / cells

Legacy certificates

Certificate number: EPT0477.MDD.19/3476.1
Type: refdata.legacy.mdd-certificate-type.ii-4
Notified body: Eurofins Product Testing Italy S.r.l. (0477)
Validity: Dec 31, 2027

Identity & classification

Basic UDI-DI: B-80565185093465A
Device name: HEART® Pericardium membrane
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class III
Version date: May 26, 2026

Manufacturer & authorised representative

Manufacturer

Name: BIOTECK S.p.A.
SRN: IT-MF-000011484
Country: Italy
Email: info@bioteck.com
Phone: +39 0444289366

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01KSHMAR59CZ2EYXSP69A4XHZW

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

HRT-005D-80565185093465A