Pricing Sign in

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

BIO-GEN® Cortical granules — 1 UDI-DI variant, MDD (BIOTECK S.p.A.)

MD Atlas
BIOTECK S.p.A.

Data from EUDAMED, last updated May 30, 2026

BIO-GEN® Cortical granules

B-805651850914854

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.

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Device characteristics

ImplantableAnimal tissues / cells

Legacy certificates

Certificate number: EPT0477.MDD.19/3474.1
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-805651850914854
Device name: BIO-GEN® Cortical granules
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

Sign in to export

Exports are reserved for signed-in users. Sign in or create an account to continue.

Email

Password

No account yet?

Export results

Applied filters

basicUdiUlid01KSJC800F84566E9ZA0T5RD2H

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

BGC-05D-805651850914854