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Sterile Rotary Files

EUDAMED

Class IIa (EU MDR)

Ref AA22007130Model U, U+, U Blue, U Grey, O, O+, X, X+, X Blue, X Grey, V, V+, V Blue, W+, W Blue, A, A+, T, T+, GF, Sun, PRG, PTF, KV, KV+, KV Blue, W+ Tunnel, Theta, KD Blue, MH, DT+, DT Blue, KM, KM Blue, EZ-PASS, Z, FSa, FSb

by Shenzhen Superline Technology Co., Ltd.

Identity

Trade Name
Sterile Rotary Files EUDAMED
Device Name
Sterile Rotary Files EUDAMED
Model / Reference
U, U+, U Blue, U Grey, O, O+, X, X+, X Blue, X Grey, V, V+, V Blue, W+, W Blue, A, A+, T, T+, GF, Sun, PRG, PTF, KV, KV+, KV Blue, W+ Tunnel, Theta, KD Blue, MH, DT+, DT Blue, KM, KM Blue, EZ-PASS, Z, FSa, FSb EUDAMED
AA22007130 EUDAMED

Identifiers

Primary DI / UDI-DI
06944835166187 EUDAMED
Basic UDI-DI
69448351ENDO03SR3N EUDAMED
Direct Marketing DI
06944835166187 EUDAMED
EMDN Code
Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Ireland EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Sterile Rotary Files by Shenzhen Superline Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Shenzhen Superline Technology Co., Ltd.
EUDAMED SRN
CN-MF-000027059
Authorised Representative
Wellkang Ltd XI-AR-000001836

Sources (1)

  • EUDAMED c723cdc2-c330-4f28-9d19-1a4966df01f9 61 fields · synced Jun 19, 2026