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

BC1 500 — Class I MDD by ROKO SP. Z O.O.

MD Atlas
ROKO SP. Z O.O.

EUDAMED last updated this device on Jan 22, 2026

BC1 500

B-05901421260880

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: ROKO SP. Z O.O.
UDI-DI code: 05901421260880
Reference / catalog number: BC1 500

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: ROKO SP. Z O.O.
SRN: PL-MF-000050171
Manufacturer status: Active

Related devices

AJ250B-05906118033440On the market AK250B-05901421260064On the market AKLB-05901421260057On the market AKMB-05901421260033On the market AKSB-05901421260040On 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

No critical warnings reported for this device.

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 Poland; available across 1 country total.

Placed on the market in Poland; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 05901421260880
Basic UDI-DI: B-05901421260880
Reference / catalog number: BC1 500
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: BIOCETAL is a material for the production of metal-free skeletal dentures. Thanks to its unique, regular and molecular structure, it has excellent physicochemical features. That means the material has dimensional stability, a low abrasion, a resistance to cyclic stress and a biotolerance. The optimal combination of stiffness and resilience as well as a mechanical strength predispose this modern technopolymer to the production of skeletal dentures and individual retention elements. The ideal chemical purity of BIOCETAL makes it a fully biocompatible material. Its neutral effect on the patient's health is confirmed by the certificates of the National Institute of Medicines.
Additional information URL: https://rokodent.pl/termoplasty/
Clinical sizes: No clinical sizes registered for this device.

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.

Q010699MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER

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