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Pre-Shaper/D3

EUDAMED

Class IIa (EU MDR)

Ref D-P.01.05-025-04-020-RB-000-00-00Model Chameleon Series - Pre-Shaper/D3 25mm S1(20/04) 6pcs/packRef D-P.01.05-025-04-035-RB-000-00-00Model Chameleon Series - Pre-Shaper/D3 25mm S3(35/04) 6pcs/packRef D-P.01.05-021-VT-0A0-RB-000-00-00Model Chameleon Series - Pre-Shaper/D3 21mm SSK#10,SSK#15,R,20/04,25/06,35/04Ref D-P.01.05-017-10-00R-RB-000-00-00Model Chameleon Series - Pre-Shaper/D3 17mm R 6pcs/packRef D-P.01.05-025-04-030-BU-000-00-00Model Pre-Shaper/D3 25mm S3 6pcs/packRef D-P.01.05-021-VT-0A0-BU-000-00-00Model Pre-Shaper/D3 25mm R-S3 6pcs/packRef D-P.01.05-031-04-035-RB-000-00-00Model Chameleon Series - Pre-Shaper/D3 31mm S3(35/04) 6pcs/packRef D-P.01.05-031-04-020-BU-000-00-00Model Pre-Shaper/D3 31mm S1 6pcs/packRef D-P.01.05-031-VT-0A0-RB-000-00-00Model Chameleon Series - Pre-Shaper/D3 31mm SSK#10,SSK#15,R,20/04,25/06,35/04 6pcs/packRef D-P.01.05-021-06-025-BU-000-00-00Model Pre-Shaper/D3 21mm S2 6pcs/packRef D-P.01.05-031-04-020-RB-000-00-00Model Chameleon Series - Pre-Shaper/D3 31mm S1(20/04) 6pcs/packRef D-P.01.05-025-04-020-BU-000-00-00Model Pre-Shaper/D3 25mm S1 6pcs/packRef D-P.01.05-021-04-020-RB-000-00-00Model Chameleon Series - Pre-Shaper/D3 21mm S1(20/04) 6pcs/packRef D-P.01.05-021-06-025-RB-000-00-00Model Chameleon Series - Pre-Shaper/D3 21mm S2(25/06) 6pcs/packRef D-P.01.05-031-06-025-RB-000-00-00Model Chameleon Series - Pre-Shaper/D3 31mm S2(25/06) 6pcs/pack

by Shenzhen Denco Medical Co., Ltd.

Identity

Trade Name
Pre-Shaper/D3 EUDAMED
Device Name
Pre-Shaper/D3 EUDAMED
Model / Reference
Chameleon Series - Pre-Shaper/D3 25mm S1(20/04) 6pcs/pack EUDAMED
D-P.01.05-025-04-020-RB-000-00-00 EUDAMED
Chameleon Series - Pre-Shaper/D3 25mm S3(35/04) 6pcs/pack EUDAMED
D-P.01.05-025-04-035-RB-000-00-00 EUDAMED
Chameleon Series - Pre-Shaper/D3 21mm SSK#10,SSK#15,R,20/04,25/06,35/04 EUDAMED
D-P.01.05-021-VT-0A0-RB-000-00-00 EUDAMED
Chameleon Series - Pre-Shaper/D3 17mm R 6pcs/pack EUDAMED
D-P.01.05-017-10-00R-RB-000-00-00 EUDAMED
Pre-Shaper/D3 25mm S3 6pcs/pack EUDAMED
D-P.01.05-025-04-030-BU-000-00-00 EUDAMED
Pre-Shaper/D3 25mm R-S3 6pcs/pack EUDAMED
D-P.01.05-021-VT-0A0-BU-000-00-00 EUDAMED
Chameleon Series - Pre-Shaper/D3 31mm S3(35/04) 6pcs/pack EUDAMED
D-P.01.05-031-04-035-RB-000-00-00 EUDAMED
Pre-Shaper/D3 31mm S1 6pcs/pack EUDAMED
D-P.01.05-031-04-020-BU-000-00-00 EUDAMED
Chameleon Series - Pre-Shaper/D3 31mm SSK#10,SSK#15,R,20/04,25/06,35/04 6pcs/pack EUDAMED
D-P.01.05-031-VT-0A0-RB-000-00-00 EUDAMED
Pre-Shaper/D3 21mm S2 6pcs/pack EUDAMED
D-P.01.05-021-06-025-BU-000-00-00 EUDAMED
Chameleon Series - Pre-Shaper/D3 31mm S1(20/04) 6pcs/pack EUDAMED
D-P.01.05-031-04-020-RB-000-00-00 EUDAMED
Pre-Shaper/D3 25mm S1 6pcs/pack EUDAMED
D-P.01.05-025-04-020-BU-000-00-00 EUDAMED
Chameleon Series - Pre-Shaper/D3 21mm S1(20/04) 6pcs/pack EUDAMED
D-P.01.05-021-04-020-RB-000-00-00 EUDAMED
Chameleon Series - Pre-Shaper/D3 21mm S2(25/06) 6pcs/pack EUDAMED
D-P.01.05-021-06-025-RB-000-00-00 EUDAMED
Chameleon Series - Pre-Shaper/D3 31mm S2(25/06) 6pcs/pack EUDAMED
D-P.01.05-031-06-025-RB-000-00-00 EUDAMED

Identifiers

Primary DI / UDI-DI
06975718052945 EUDAMED
06975718052969 EUDAMED
06975718052884 EUDAMED
06975718052860 EUDAMED
06970514913063 EUDAMED
06970514914138 EUDAMED
06975718053010 EUDAMED
06970514913070 EUDAMED
06975718052983 EUDAMED
06970514913025 EUDAMED
06975718052990 EUDAMED
06970514913049 EUDAMED
06975718052891 EUDAMED
06975718052907 EUDAMED
06975718053003 EUDAMED
Basic UDI-DI
B-06975718052945 EUDAMED
B-06975718052969 EUDAMED
B-06975718052884 EUDAMED
B-06975718052860 EUDAMED
B-06970514913063 EUDAMED
B-06970514914138 EUDAMED
B-06975718053010 EUDAMED
B-06970514913070 EUDAMED
B-06975718052983 EUDAMED
B-06970514913025 EUDAMED
B-06975718052990 EUDAMED
B-06970514913049 EUDAMED
B-06975718052891 EUDAMED
B-06975718052907 EUDAMED
B-06975718053003 EUDAMED
EMDN Code
Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Türkiye EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Pre-Shaper/D3 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

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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 (15)

  • EUDAMED d0c037e6-7196-494c-95e8-99a5ca5280d4 61 fields · synced Sep 17, 2026
  • EUDAMED 3329f619-d3dd-4c8e-9448-ad77bd69b342 61 fields · synced May 16, 2026
  • EUDAMED e0e9c3d5-160a-4ec3-9b62-cb7c95c50748 61 fields · synced May 16, 2026
  • EUDAMED 9ae39382-15e9-4485-827a-7c656db3f29f 61 fields · synced May 16, 2026
  • EUDAMED 2d23a2ba-b5c1-428a-a5d3-c14ed3f1e2bd 61 fields · synced May 17, 2026
  • EUDAMED 36de687a-41e0-4bb8-b0d5-b639dc28686a 61 fields · synced May 17, 2026
  • EUDAMED d237ef64-9799-4dc7-bd91-1f14b83cfd83 61 fields · synced May 18, 2026
  • EUDAMED 86fb4e34-4059-4ef5-8367-f4bc7ced01bb 61 fields · synced May 18, 2026
  • EUDAMED d3e59894-854b-457f-87e1-ea63f5adbcaa 61 fields · synced May 18, 2026
  • EUDAMED 00035546-839a-4b83-a361-5134be7093a4 61 fields · synced May 18, 2026
  • EUDAMED 9bc72429-50b0-4ce5-89bc-ae14079060a6 61 fields · synced May 18, 2026
  • EUDAMED daa3db40-7fbf-49af-ac0a-b83c3e4e0462 61 fields · synced May 19, 2026
  • EUDAMED d3e3863e-ef5c-406a-bac1-f697d2016be2 61 fields · synced May 19, 2026
  • EUDAMED 2c3f37e2-6da8-4679-995a-08ee373118ec 61 fields · synced May 19, 2026
  • EUDAMED 68eac0b0-3fde-4e88-852f-196c3de2867a 61 fields · synced May 19, 2026