Pricing Sign in

Role
Country
Date of registration
Address

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.

Organization name
UDI-DI code
Reference / catalog number

OGS-ACM601 — Class III MDD by BIOTECK S.p.A.

MD Atlas
BIOTECK S.p.A.

EUDAMED last updated this device on May 22, 2026

OGS-ACM601

B-80565185027984Y

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: BIOTECK S.p.A.
UDI-DI code: D-80565185027984Y
Reference / catalog number: OGS-ACM601

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?

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

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.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Feb 15, 1999	Dec 31, 2027

Device identification

Trade name: not provided
UDI-DI code: D-80565185027984Y
Basic UDI-DI: B-80565185027984Y
Reference / catalog number: OGS-ACM601
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: DBM Mouldable Paste - 1 syr / 1 cc
Additional information URL: https://bioteck.com/bosp
Clinical sizes: 1 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.

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

Become a partner of MD Atlas

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.