Sample BlueShaper PRO sterile files

EUDAMED

Class IIa (EU MDR)

Ref SPLEBS25APRO4Model Sample BlueShaper PRO sterile files 25mm Z1-Z4 (4 units) Training KitRef SPLEBS25APROSModel Sample BlueShaper PRO sterile files 25mm ZXS-Z5 (6 units)

by Shenzhen Denco Medical Co., Ltd.

Identity

Trade Name: Sample BlueShaper PRO sterile files EUDAMED
Device Name: Sample BlueShaper PRO sterile files EUDAMED
Model / Reference: Sample BlueShaper PRO sterile files 25mm Z1-Z4 (4 units) Training Kit EUDAMED
SPLEBS25APRO4 EUDAMED
Sample BlueShaper PRO sterile files 25mm ZXS-Z5 (6 units) EUDAMED
SPLEBS25APROS EUDAMED

Identifiers

Primary DI / UDI-DI: 06942512509579 EUDAMED
06942512509647 EUDAMED
Basic UDI-DI: B-06942512509579 EUDAMED
B-06942512509647 EUDAMED
EMDN Code: Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Spain EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Sample BlueShaper PRO sterile files by Shenzhen Denco Medical Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-06942512509579	Class IIa	Active

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Manufacturer

Manufacturer: Shenzhen Denco Medical Co., Ltd.
EUDAMED SRN: CN-MF-000014271
Authorised Representative: Share info GmbH DE-AR-000005132

Sources (2)

EUDAMED f86d3847-2bdf-47d7-adec-a7c00e707906 61 fields · synced Jul 31, 2026
EUDAMED 36a9e359-007a-4775-9495-1387ae666dcd 61 fields · synced May 18, 2026