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D-Shaper

EUDAMED

Class IIa (EU MDR)

Ref D-P.01.06-025-06-035-GD-000-00-00Model D-SHAPER 25mm 35/06 6pcs/packRef D-P.01.06-025-VT-016-RB-000-00-00Model Chameleon Series - D-SHAPER 25mm 016 6pcs/packRef D-P.01.06-031-04-0S3-RB-000-00-00Model Chameleon Series - D-SHAPER 31mm S3(30/04) 6pcs/packRef D-P.01.06-021-06-0S4-GD-000-00-00Model D-SHAPER 21mm S4 6pcs/packRef D-P.01.06-031-VT-0A0-RB-000-00-00Model Chameleon Series - D-SHAPER 31mm R,016,S1(20/04),S2(25/04),S3(30/04),S4(25/06) 6pcs/packRef D-P.01.06-021-VT-016-GD-000-00-00Model D-SHAPER 21mm 016 6pcs/packRef D-P.01.06-025-04-040-RB-000-00-00Model Chameleon Series - D-SHAPER 25mm 40/04 6pcs/packRef D-P.01.06-021-04-035-RB-000-00-00Model Chameleon Series - D-SHAPER 21mm 35/04 6pcs/packRef D-P.01.06-031-04-0A1-RB-000-00-00Model Chameleon Series - D-SHAPER 31mm 35/04,35/04,40/04,40/04,50/04,50/04 6pcs/packRef D-P.01.06-031-04-035-RB-000-00-00Model Chameleon Series - D-SHAPER 31mm 35/04 6pcs/packRef D-P.01.06-025-06-0S4-GD-000-00-00Model D-SHAPER 25mm S4 6pcs/packRef D-P.01.06-017-10-00R-GD-000-00-00Model D-SHAPER 17mm R 6pcs/packRef D-P.01.06-021-04-0S1-RB-000-00-00Model Chameleon Series - D-SHAPER 21mm S1(20/04) 6pcs/packRef D-P.01.06-031-VT-016-RB-000-00-00Model Chameleon Series - D-SHAPER 31mm 016 6pcs/packRef D-P.01.06-031-06-0S4-RB-000-00-00Model Chameleon Series - D-SHAPER 31mm S4(25/06) 6pcs/packRef D-P.01.06-017-10-00R-RB-000-00-00Model Chameleon Series - D-SHAPER 17mm R 6pcs/packRef D-P.01.06-025-04-0S3-RB-000-00-00Model Chameleon Series - D-SHAPER 25mm S3(30/04) 6pcs/packRef D-P.01.06-025-04-050-RB-000-00-00Model Chameleon Series - D-SHAPER 25mm 50/04 6pcs/packRef D-P.01.06-025-04-0S1-RB-000-00-00Model Chameleon Series - D-SHAPER 25mm S1(20/04) 6pcs/packRef D-P.01.06-025-04-035-RB-000-00-00Model Chameleon Series - D-SHAPER 25mm 35/04 6pcs/packRef D-P.01.06-025-04-0A1-RB-000-00-00Model Chameleon Series - D-SHAPER 25mm 35/04,35/04,/40/04,40/04,50/04,50/04 6pcs/packRef D-P.01.06-031-06-0S4-GD-000-00-00Model D-SHAPER 31mm S4 6pcs/packRef D-P.01.06-025-VT-016-GD-000-00-00Model D-SHAPER 25mm 016 6pcs/packRef D-P.01.06-021-04-0S1-GD-000-00-00Model D-SHAPER 21mm S1 6pcs/packRef D-P.01.06-025-06-035-RB-000-00-00Model Chameleon Series - D-SHAPER 25mm 35/06 6pcs/packRef D-P.01.06-031-VT-016-GD-000-00-00Model D-SHAPER 31mm 016 6pcs/packRef D-P.01.06-031-04-0S3-GD-000-00-00Model D-SHAPER 31mm S3 6pcs/packRef D-P.01.06-025-04-0S1-GD-000-00-00Model D-SHAPER 25mm S1 6pcs/packRef D-P.01.06-025-04-0S3-GD-000-00-00Model D-SHAPER 25mm S3 6pcs/packRef D-P.01.06-025-04-035-GD-000-00-00Model D-SHAPER 25mm 35/04 6pcs/packRef D-P.01.06-021-04-0S2-RB-000-00-00Model Chameleon Series - D-SHAPER 21mm S2(25/04) 6pcs/pack

by Shenzhen Denco Medical Co., Ltd.

Identity

Trade Name
D-SHAPER EUDAMED
Device Name
D-SHAPER EUDAMED
Model / Reference
D-SHAPER 25mm 35/06 6pcs/pack EUDAMED
D-P.01.06-025-06-035-GD-000-00-00 EUDAMED
Chameleon Series - D-SHAPER 25mm 016 6pcs/pack EUDAMED
D-P.01.06-025-VT-016-RB-000-00-00 EUDAMED
Chameleon Series - D-SHAPER 31mm S3(30/04) 6pcs/pack EUDAMED
D-P.01.06-031-04-0S3-RB-000-00-00 EUDAMED
D-SHAPER 21mm S4 6pcs/pack EUDAMED
D-P.01.06-021-06-0S4-GD-000-00-00 EUDAMED
Chameleon Series - D-SHAPER 31mm R,016,S1(20/04),S2(25/04),S3(30/04),S4(25/06) 6pcs/pack EUDAMED
D-P.01.06-031-VT-0A0-RB-000-00-00 EUDAMED
D-SHAPER 21mm 016 6pcs/pack EUDAMED
D-P.01.06-021-VT-016-GD-000-00-00 EUDAMED
Chameleon Series - D-SHAPER 25mm 40/04 6pcs/pack EUDAMED
D-P.01.06-025-04-040-RB-000-00-00 EUDAMED
Chameleon Series - D-SHAPER 21mm 35/04 6pcs/pack EUDAMED
D-P.01.06-021-04-035-RB-000-00-00 EUDAMED
Chameleon Series - D-SHAPER 31mm 35/04,35/04,40/04,40/04,50/04,50/04 6pcs/pack EUDAMED
D-P.01.06-031-04-0A1-RB-000-00-00 EUDAMED
Chameleon Series - D-SHAPER 31mm 35/04 6pcs/pack EUDAMED
D-P.01.06-031-04-035-RB-000-00-00 EUDAMED
D-SHAPER 25mm S4 6pcs/pack EUDAMED
D-P.01.06-025-06-0S4-GD-000-00-00 EUDAMED
D-SHAPER 17mm R 6pcs/pack EUDAMED
D-P.01.06-017-10-00R-GD-000-00-00 EUDAMED
Chameleon Series - D-SHAPER 21mm S1(20/04) 6pcs/pack EUDAMED
D-P.01.06-021-04-0S1-RB-000-00-00 EUDAMED
Chameleon Series - D-SHAPER 31mm 016 6pcs/pack EUDAMED
D-P.01.06-031-VT-016-RB-000-00-00 EUDAMED
Chameleon Series - D-SHAPER 31mm S4(25/06) 6pcs/pack EUDAMED
D-P.01.06-031-06-0S4-RB-000-00-00 EUDAMED
Chameleon Series - D-SHAPER 17mm R 6pcs/pack EUDAMED
D-P.01.06-017-10-00R-RB-000-00-00 EUDAMED
Chameleon Series - D-SHAPER 25mm S3(30/04) 6pcs/pack EUDAMED
D-P.01.06-025-04-0S3-RB-000-00-00 EUDAMED
Chameleon Series - D-SHAPER 25mm 50/04 6pcs/pack EUDAMED
D-P.01.06-025-04-050-RB-000-00-00 EUDAMED
Chameleon Series - D-SHAPER 25mm S1(20/04) 6pcs/pack EUDAMED
D-P.01.06-025-04-0S1-RB-000-00-00 EUDAMED
Chameleon Series - D-SHAPER 25mm 35/04 6pcs/pack EUDAMED
D-P.01.06-025-04-035-RB-000-00-00 EUDAMED
Chameleon Series - D-SHAPER 25mm 35/04,35/04,/40/04,40/04,50/04,50/04 6pcs/pack EUDAMED
D-P.01.06-025-04-0A1-RB-000-00-00 EUDAMED
D-SHAPER 31mm S4 6pcs/pack EUDAMED
D-P.01.06-031-06-0S4-GD-000-00-00 EUDAMED
D-SHAPER 25mm 016 6pcs/pack EUDAMED
D-P.01.06-025-VT-016-GD-000-00-00 EUDAMED
D-SHAPER 21mm S1 6pcs/pack EUDAMED
D-P.01.06-021-04-0S1-GD-000-00-00 EUDAMED
Chameleon Series - D-SHAPER 25mm 35/06 6pcs/pack EUDAMED
D-P.01.06-025-06-035-RB-000-00-00 EUDAMED
D-SHAPER 31mm 016 6pcs/pack EUDAMED
D-P.01.06-031-VT-016-GD-000-00-00 EUDAMED
D-SHAPER 31mm S3 6pcs/pack EUDAMED
D-P.01.06-031-04-0S3-GD-000-00-00 EUDAMED
D-SHAPER 25mm S1 6pcs/pack EUDAMED
D-P.01.06-025-04-0S1-GD-000-00-00 EUDAMED
D-SHAPER 25mm S3 6pcs/pack EUDAMED
D-P.01.06-025-04-0S3-GD-000-00-00 EUDAMED
D-SHAPER 25mm 35/04 6pcs/pack EUDAMED
D-P.01.06-025-04-035-GD-000-00-00 EUDAMED
Chameleon Series - D-SHAPER 21mm S2(25/04) 6pcs/pack EUDAMED
D-P.01.06-021-04-0S2-RB-000-00-00 EUDAMED

Identifiers

Primary DI / UDI-DI
06942512507537 EUDAMED
06975718054710 EUDAMED
06975718054895 EUDAMED
06970514918921 EUDAMED
06975718054826 EUDAMED
06970514918884 EUDAMED
06975718054741 EUDAMED
06975718054635 EUDAMED
06975718054864 EUDAMED
06975718054833 EUDAMED
06970514919362 EUDAMED
06970514918877 EUDAMED
06975718054673 EUDAMED
06975718054819 EUDAMED
06975718054901 EUDAMED
06975718054604 EUDAMED
06975718054796 EUDAMED
06975718054758 EUDAMED
06975718054772 EUDAMED
06975718054734 EUDAMED
06975718054765 EUDAMED
06970514919423 EUDAMED
06970514919324 EUDAMED
06970514918891 EUDAMED
06942512507902 EUDAMED
06970514919386 EUDAMED
06970514919416 EUDAMED
06970514919331 EUDAMED
06970514919355 EUDAMED
06942512507513 EUDAMED
06975718054680 EUDAMED
Basic UDI-DI
B-06942512507537 EUDAMED
B-06975718054710 EUDAMED
B-06975718054895 EUDAMED
B-06970514918921 EUDAMED
B-06975718054826 EUDAMED
B-06970514918884 EUDAMED
B-06975718054741 EUDAMED
B-06975718054635 EUDAMED
B-06975718054864 EUDAMED
B-06975718054833 EUDAMED
B-06970514919362 EUDAMED
B-06970514918877 EUDAMED
B-06975718054673 EUDAMED
B-06975718054819 EUDAMED
B-06975718054901 EUDAMED
B-06975718054604 EUDAMED
B-06975718054796 EUDAMED
B-06975718054758 EUDAMED
B-06975718054772 EUDAMED
B-06975718054734 EUDAMED
B-06975718054765 EUDAMED
B-06970514919423 EUDAMED
B-06970514919324 EUDAMED
B-06970514918891 EUDAMED
B-06942512507902 EUDAMED
B-06970514919386 EUDAMED
B-06970514919416 EUDAMED
B-06970514919331 EUDAMED
B-06970514919355 EUDAMED
B-06942512507513 EUDAMED
B-06975718054680 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
Denmark 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

EUDAMEDEUDAMED

Animal Tissues

No

EUDAMEDEUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

D-Shaper 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 (31)

  • EUDAMED 7026539c-d9b7-4f58-aebd-9f62d81706fa 61 fields · synced Aug 3, 2026
  • EUDAMED 92db6fd0-e83b-497a-b4a8-858ebadc2ed1 61 fields · synced May 11, 2026
  • EUDAMED ec694353-5521-4e3d-9bf2-83b61d4ece78 61 fields · synced May 16, 2026
  • EUDAMED 58b24c3e-05f2-4117-8975-a1cbd0e5c961 61 fields · synced May 16, 2026
  • EUDAMED edb17d1c-5970-49bd-834e-69311ff52271 61 fields · synced May 16, 2026
  • EUDAMED 4f640e70-ffdc-4ba7-bcb4-419266af1ec0 61 fields · synced May 17, 2026
  • EUDAMED d53e133d-7688-4773-8d55-5b1d9ba3c0a7 61 fields · synced May 17, 2026
  • EUDAMED 87c503cb-0efd-4796-9d0d-1de9b11bdd09 61 fields · synced May 17, 2026
  • EUDAMED 394247fc-f825-491f-8f08-4011bdb56912 61 fields · synced May 17, 2026
  • EUDAMED 20e87c40-06bf-477c-8109-fb78785561f6 61 fields · synced May 17, 2026
  • EUDAMED 89659ec0-ed9b-47cc-b527-1da8554055e3 61 fields · synced May 17, 2026
  • EUDAMED feb3d58f-62b9-447a-8f15-0fd38b49f725 61 fields · synced May 17, 2026
  • EUDAMED 10778d41-c62d-410e-9e90-a14236cd95ab 61 fields · synced May 17, 2026
  • EUDAMED a8ae8e09-b02c-47dd-ac6b-8e6930dff99e 61 fields · synced May 17, 2026
  • EUDAMED 116c9253-16fa-43e3-8aba-7bfd7563292f 61 fields · synced May 17, 2026
  • EUDAMED 94f807d3-5e72-490c-ba51-708e67fac9c1 61 fields · synced May 17, 2026
  • EUDAMED a88cc1c8-73bb-4626-91a8-b3ec876d941d 61 fields · synced May 18, 2026
  • EUDAMED 8952366e-2161-4638-b4c3-416117e10668 61 fields · synced May 18, 2026
  • EUDAMED 7924e1db-c2cd-4449-a1a6-ecc02c595cc2 61 fields · synced May 18, 2026
  • EUDAMED 422aab20-621f-40e2-be2e-e2912c3cf996 61 fields · synced May 18, 2026
  • EUDAMED 52bd8729-0051-49e2-ae0d-f1c2cdf1dc97 61 fields · synced May 18, 2026
  • EUDAMED d2a4bd53-4cee-46a7-a182-e39f15bfdee5 61 fields · synced May 18, 2026
  • EUDAMED 55d06303-a78a-416d-af3f-0ebe7d6510dc 61 fields · synced May 18, 2026
  • EUDAMED 8a5a1d9a-7207-4d05-bb95-65bdf9212571 61 fields · synced May 19, 2026
  • EUDAMED 080a3899-d431-416e-bba8-3bc6ace6fd14 61 fields · synced May 19, 2026
  • EUDAMED b4f2263c-7285-47c1-bf03-bf68de5b24ca 61 fields · synced May 19, 2026
  • EUDAMED a059bf75-e9ca-48ca-b951-26ad7170b4d3 61 fields · synced May 19, 2026
  • EUDAMED 67bc1ca9-97ab-4661-bd3d-ab7db8647f06 61 fields · synced May 19, 2026
  • EUDAMED 4d15c384-2f47-4fa8-84a8-78b09fe74388 61 fields · synced May 19, 2026
  • EUDAMED cf71cc02-2f5a-4f75-a51a-bb93d06c5059 61 fields · synced May 19, 2026
  • EUDAMED f4493d05-6323-47b4-8015-7a9e0970b80f 61 fields · synced May 19, 2026