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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

BB3 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

BB3 500

B-05901421260781

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: ROKO SP. Z O.O.
UDI-DI code: 05901421260781
Reference / catalog number: BB3 500

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Manufacturer information

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

Critical warnings

No critical warnings reported for this device.

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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: 05901421260781
Basic UDI-DI: B-05901421260781
Reference / catalog number: BB3 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

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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.