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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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Biocetal B4L — 1 UDI-DI variant, MDD (ROKO SP. Z O.O.)

MD Atlas
ROKO SP. Z O.O.

Data from EUDAMED, last updated May 30, 2026

Biocetal B4L

B-05901421260811

1 UDI-DI variant

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

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class I
Manufacturer: ROKO SP. Z O.O.

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: B-05901421260811
Device name: Biocetal B4L
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class I
Version date: Jan 23, 2026

Manufacturer & authorised representative

Manufacturer

Name: ROKO SP. Z O.O.
SRN: PL-MF-000050171
Country: Poland
Email: ROKODENT@ROKODENT.PL
Phone: +48 343697821

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01KFN2JT539ZDSJM0R853VMKZ9

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

BB4L05901421260811