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NiTi H Files

EUDAMED

Class IIa (EU MDR)

Ref CODE36H21NT25Model E36 NiTi H Files 6s 21mm No.25Ref CODE36H21NT55Model E36 NiTi H Files 6s 21mm No.55Ref CODE36H21NT80Model E36 NiTi H Files 6s 21mm No.80Ref CODE36H25NT60Model E36 NiTi H Files 6s 25mm No.60Ref CODE36H25NT4580Model E36 NiTi H Files 6s 25mm No.45-80 Asst.Ref CODE36H25NT70Model E36 NiTi H Files 6s 25mm No.70Ref CODE36H25NT80Model E36 NiTi H Files 6s 25mm No.80Ref CODE36H25NT40Model E36 NiTi H Files 6s 25mm No.40Ref CODE36H25NT25Model E36 NiTi H Files 6s 25mm No.25Ref CODE36H25NT1540Model E36 NiTi H Files 6s 25mm No.15-40 Asst.Ref CODE36H21NT50Model E36 NiTi H Files 6s 21mm No.50Ref CODE36H25NT50Model E36 NiTi H Files 6s 25mm No.50Ref CODE36H21NT15Model E36 NiTi H Files 6s 21mm No.15Ref CODE36H21NT40Model E36 NiTi H Files 6s 21mm No.40Ref CODE36H25NT15Model E36 NiTi H Files 6s 25mm No.15Ref CODE36H21NT60Model E36 NiTi H Files 6s 21mm No.60Ref CODE36H21NT30Model E36 NiTi H Files 6s 21mm No.30Ref CODE36H21NT20Model E36 NiTi H Files 6s 21mm No.20Ref D-P.03.02-028-02-0A1-SR-000-00-00Model NITI H-Files 28mm #45-80 6pcs/packRef D-P.03.02-031-02-025-SR-000-00-00Model NITI H-Files 31mm #25 6pcs/packRef D-P.03.02-028-02-050-SR-000-00-00Model NITI H-Files 28mm #50 6pcs/packRef D-P.03.02-021-02-055-SR-000-00-00Model NITI H-Files 21mm #55 6pcs/packRef D-P.03.02-025-02-070-SR-000-00-00Model NITI H-Files 25mm #70 6pcs/packRef D-P.03.02-028-02-060-SR-000-00-00Model NITI H-Files 28mm #60 6pcs/packRef D-P.03.02-021-02-015-SR-000-00-00Model NITI H-Files 21mm #15 6pcs/packRef D-P.03.02-025-02-035-SR-000-00-00Model NITI H-Files 25mm #35 6pcs/packRef D-P.03.02-025-02-080-SR-000-00-00Model NITI H-Files 25mm #80 6pcs/packRef D-P.03.02-028-02-055-SR-000-00-00Model NITI H-Files 28mm #55 6pcs/packRef D-P.03.02-025-02-050-SR-000-00-00Model NITI H-Files 25mm #50 6pcs/packRef D-P.03.02-031-02-030-SR-000-00-00Model NITI H-Files 31mm #30 6pcs/packRef D-P.03.02-028-02-015-SR-000-00-00Model NITI H-Files 28mm #15 6pcs/packRef D-P.03.02-025-02-020-SR-000-00-00Model NITI H-Files 25mm #20 6pcs/packRef D-P.03.02-021-02-010-SR-000-00-00Model NITI H-Files 21mm #10 6pcs/packRef D-P.03.02-028-02-070-SR-000-00-00Model NITI H-Files 28mm #70 6pcs/packRef D-P.03.02-031-02-050-SR-000-00-00Model NITI H-Files 31mm #50 6pcs/packRef D-P.03.02-025-02-040-SR-000-00-00Model NITI H-Files 25mm #40 6pcs/packRef D-P.03.02-025-02-025-SR-000-00-00Model NITI H-Files 25mm #25 6pcs/packRef D-P.03.02-021-02-020-SR-000-00-00Model NITI H-Files 21mm #20 6pcs/packRef D-P.03.02-021-02-030-SR-000-00-00Model NITI H-Files 21mm #30 6pcs/packRef D-P.03.02-021-02-050-SR-000-00-00Model NITI H-Files 21mm #50 6pcs/packRef D-P.03.02-021-02-060-SR-000-00-00Model NITI H-Files 21mm #60 6pcs/packRef D-P.03.02-028-02-010-SR-000-00-00Model NITI H-Files 28mm #10 6pcs/packRef D-P.03.02-025-02-0A1-SR-000-00-00Model NITI H-Files 25mm #45-80 6pcs/packRef D-P.03.02-021-02-080-SR-000-00-00Model NITI H-Files 21mm #80 6pcs/packRef D-P.03.02-025-02-045-SR-000-00-00Model NITI H-Files 25mm #45 6pcs/packRef D-P.03.02-028-02-0A0-SR-000-00-00Model NITI H-Files 28mm #15-40 6pcs/packRef D-P.03.02-025-02-008-SR-000-00-00Model NITI H-Files 25mm #08 6pcs/packRef D-P.03.02-028-02-030-SR-000-00-00Model NITI H-Files 28mm #30 6pcs/packRef D-P.03.02-031-02-0A1-SR-000-00-00Model NITI H-Files 31mm #45-80 6pcs/packRef D-P.03.02-025-02-0A0-SR-000-00-00Model NITI H-Files 25mm #15-40 6pcs/pack

by Shenzhen Denco Medical Co., Ltd.

Identity

Trade Name
NiTi H Files EUDAMED
NITI H-Files EUDAMED
Device Name
Dental Root Canal Instruments Files EUDAMED
NITI H-Files EUDAMED
Model / Reference
E36 NiTi H Files 6s 21mm No.25 EUDAMED
CODE36H21NT25 EUDAMED
E36 NiTi H Files 6s 21mm No.55 EUDAMED
CODE36H21NT55 EUDAMED
E36 NiTi H Files 6s 21mm No.80 EUDAMED
CODE36H21NT80 EUDAMED
E36 NiTi H Files 6s 25mm No.60 EUDAMED
CODE36H25NT60 EUDAMED
E36 NiTi H Files 6s 25mm No.45-80 Asst. EUDAMED
CODE36H25NT4580 EUDAMED
E36 NiTi H Files 6s 25mm No.70 EUDAMED
CODE36H25NT70 EUDAMED
E36 NiTi H Files 6s 25mm No.80 EUDAMED
CODE36H25NT80 EUDAMED
E36 NiTi H Files 6s 25mm No.40 EUDAMED
CODE36H25NT40 EUDAMED
E36 NiTi H Files 6s 25mm No.25 EUDAMED
CODE36H25NT25 EUDAMED
E36 NiTi H Files 6s 25mm No.15-40 Asst. EUDAMED
CODE36H25NT1540 EUDAMED
E36 NiTi H Files 6s 21mm No.50 EUDAMED
CODE36H21NT50 EUDAMED
E36 NiTi H Files 6s 25mm No.50 EUDAMED
CODE36H25NT50 EUDAMED
E36 NiTi H Files 6s 21mm No.15 EUDAMED
CODE36H21NT15 EUDAMED
E36 NiTi H Files 6s 21mm No.40 EUDAMED
CODE36H21NT40 EUDAMED
E36 NiTi H Files 6s 25mm No.15 EUDAMED
CODE36H25NT15 EUDAMED
E36 NiTi H Files 6s 21mm No.60 EUDAMED
CODE36H21NT60 EUDAMED
E36 NiTi H Files 6s 21mm No.30 EUDAMED
CODE36H21NT30 EUDAMED
E36 NiTi H Files 6s 21mm No.20 EUDAMED
CODE36H21NT20 EUDAMED
NITI H-Files 28mm #45-80 6pcs/pack EUDAMED
D-P.03.02-028-02-0A1-SR-000-00-00 EUDAMED
NITI H-Files 31mm #25 6pcs/pack EUDAMED
D-P.03.02-031-02-025-SR-000-00-00 EUDAMED
NITI H-Files 28mm #50 6pcs/pack EUDAMED
D-P.03.02-028-02-050-SR-000-00-00 EUDAMED
NITI H-Files 21mm #55 6pcs/pack EUDAMED
D-P.03.02-021-02-055-SR-000-00-00 EUDAMED
NITI H-Files 25mm #70 6pcs/pack EUDAMED
D-P.03.02-025-02-070-SR-000-00-00 EUDAMED
NITI H-Files 28mm #60 6pcs/pack EUDAMED
D-P.03.02-028-02-060-SR-000-00-00 EUDAMED
NITI H-Files 21mm #15 6pcs/pack EUDAMED
D-P.03.02-021-02-015-SR-000-00-00 EUDAMED
NITI H-Files 25mm #35 6pcs/pack EUDAMED
D-P.03.02-025-02-035-SR-000-00-00 EUDAMED
NITI H-Files 25mm #80 6pcs/pack EUDAMED
D-P.03.02-025-02-080-SR-000-00-00 EUDAMED
NITI H-Files 28mm #55 6pcs/pack EUDAMED
D-P.03.02-028-02-055-SR-000-00-00 EUDAMED
NITI H-Files 25mm #50 6pcs/pack EUDAMED
D-P.03.02-025-02-050-SR-000-00-00 EUDAMED
NITI H-Files 31mm #30 6pcs/pack EUDAMED
D-P.03.02-031-02-030-SR-000-00-00 EUDAMED
NITI H-Files 28mm #15 6pcs/pack EUDAMED
D-P.03.02-028-02-015-SR-000-00-00 EUDAMED
NITI H-Files 25mm #20 6pcs/pack EUDAMED
D-P.03.02-025-02-020-SR-000-00-00 EUDAMED
NITI H-Files 21mm #10 6pcs/pack EUDAMED
D-P.03.02-021-02-010-SR-000-00-00 EUDAMED
NITI H-Files 28mm #70 6pcs/pack EUDAMED
D-P.03.02-028-02-070-SR-000-00-00 EUDAMED
NITI H-Files 31mm #50 6pcs/pack EUDAMED
D-P.03.02-031-02-050-SR-000-00-00 EUDAMED
NITI H-Files 25mm #40 6pcs/pack EUDAMED
D-P.03.02-025-02-040-SR-000-00-00 EUDAMED
NITI H-Files 25mm #25 6pcs/pack EUDAMED
D-P.03.02-025-02-025-SR-000-00-00 EUDAMED
NITI H-Files 21mm #20 6pcs/pack EUDAMED
D-P.03.02-021-02-020-SR-000-00-00 EUDAMED
NITI H-Files 21mm #30 6pcs/pack EUDAMED
D-P.03.02-021-02-030-SR-000-00-00 EUDAMED
NITI H-Files 21mm #50 6pcs/pack EUDAMED
D-P.03.02-021-02-050-SR-000-00-00 EUDAMED
NITI H-Files 21mm #60 6pcs/pack EUDAMED
D-P.03.02-021-02-060-SR-000-00-00 EUDAMED
NITI H-Files 28mm #10 6pcs/pack EUDAMED
D-P.03.02-028-02-010-SR-000-00-00 EUDAMED
NITI H-Files 25mm #45-80 6pcs/pack EUDAMED
D-P.03.02-025-02-0A1-SR-000-00-00 EUDAMED
NITI H-Files 21mm #80 6pcs/pack EUDAMED
D-P.03.02-021-02-080-SR-000-00-00 EUDAMED
NITI H-Files 25mm #45 6pcs/pack EUDAMED
D-P.03.02-025-02-045-SR-000-00-00 EUDAMED
NITI H-Files 28mm #15-40 6pcs/pack EUDAMED
D-P.03.02-028-02-0A0-SR-000-00-00 EUDAMED
NITI H-Files 25mm #08 6pcs/pack EUDAMED
D-P.03.02-025-02-008-SR-000-00-00 EUDAMED
NITI H-Files 28mm #30 6pcs/pack EUDAMED
D-P.03.02-028-02-030-SR-000-00-00 EUDAMED
NITI H-Files 31mm #45-80 6pcs/pack EUDAMED
D-P.03.02-031-02-0A1-SR-000-00-00 EUDAMED
NITI H-Files 25mm #15-40 6pcs/pack EUDAMED
D-P.03.02-025-02-0A0-SR-000-00-00 EUDAMED

Identifiers

Primary DI / UDI-DI
06942512505816 EUDAMED
06942512505885 EUDAMED
06942512505915 EUDAMED
06942512506042 EUDAMED
06942512506011 EUDAMED
06942512506059 EUDAMED
06942512506066 EUDAMED
06942512505991 EUDAMED
06942512505960 EUDAMED
06942512505946 EUDAMED
06942512505878 EUDAMED
06942512506028 EUDAMED
06942512505786 EUDAMED
06942512505847 EUDAMED
06942512505939 EUDAMED
06942512505892 EUDAMED
06942512505823 EUDAMED
06942512505809 EUDAMED
06970514914763 EUDAMED
06970514914862 EUDAMED
06970514914718 EUDAMED
06970514915487 EUDAMED
06970514914824 EUDAMED
06970514914732 EUDAMED
06970514915401 EUDAMED
06970514910550 EUDAMED
06970514914831 EUDAMED
06970514914725 EUDAMED
06970514914794 EUDAMED
06970514914879 EUDAMED
06970514910598 EUDAMED
06970514910529 EUDAMED
06970514915395 EUDAMED
06970514914749 EUDAMED
06970514914916 EUDAMED
06970514914770 EUDAMED
06970514910536 EUDAMED
06970514915418 EUDAMED
06970514915432 EUDAMED
06970514915470 EUDAMED
06970514915494 EUDAMED
06970514910581 EUDAMED
06970514914848 EUDAMED
06970514915517 EUDAMED
06970514914787 EUDAMED
06970514910642 EUDAMED
06970514910499 EUDAMED
06970514910628 EUDAMED
06970514914978 EUDAMED
06970514910567 EUDAMED
Basic UDI-DI
B-06942512505816 EUDAMED
B-06942512505885 EUDAMED
B-06942512505915 EUDAMED
B-06942512506042 EUDAMED
B-06942512506011 EUDAMED
B-06942512506059 EUDAMED
B-06942512506066 EUDAMED
B-06942512505991 EUDAMED
B-06942512505960 EUDAMED
B-06942512505946 EUDAMED
B-06942512505878 EUDAMED
B-06942512506028 EUDAMED
B-06942512505786 EUDAMED
B-06942512505847 EUDAMED
B-06942512505939 EUDAMED
B-06942512505892 EUDAMED
B-06942512505823 EUDAMED
B-06942512505809 EUDAMED
B-06970514914763 EUDAMED
B-06970514914862 EUDAMED
B-06970514914718 EUDAMED
B-06970514915487 EUDAMED
B-06970514914824 EUDAMED
B-06970514914732 EUDAMED
B-06970514915401 EUDAMED
B-06970514910550 EUDAMED
B-06970514914831 EUDAMED
B-06970514914725 EUDAMED
B-06970514914794 EUDAMED
B-06970514914879 EUDAMED
B-06970514910598 EUDAMED
B-06970514910529 EUDAMED
B-06970514915395 EUDAMED
B-06970514914749 EUDAMED
B-06970514914916 EUDAMED
B-06970514914770 EUDAMED
B-06970514910536 EUDAMED
B-06970514915418 EUDAMED
B-06970514915432 EUDAMED
B-06970514915470 EUDAMED
B-06970514915494 EUDAMED
B-06970514910581 EUDAMED
B-06970514914848 EUDAMED
B-06970514915517 EUDAMED
B-06970514914787 EUDAMED
B-06970514910642 EUDAMED
B-06970514910499 EUDAMED
B-06970514910628 EUDAMED
B-06970514914978 EUDAMED
B-06970514910567 EUDAMED
EMDN Code
Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Poland EUDAMED
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

NiTi H 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (50)

  • EUDAMED dcb86d24-4228-42b6-81c0-d7d8615c8a87 61 fields · synced Sep 30, 2026
  • EUDAMED a224d746-43b5-4d77-bf09-143c0efc26f2 61 fields · synced May 16, 2026
  • EUDAMED aaef1b85-fe9c-4ab3-8822-d455cef92064 61 fields · synced May 16, 2026
  • EUDAMED 16ebef28-bead-4823-935d-8390e592f86f 61 fields · synced May 17, 2026
  • EUDAMED 44843a77-f456-4ead-9e3a-c56a56ac2027 61 fields · synced May 17, 2026
  • EUDAMED b49ab51f-f0b8-4d86-803d-21344ba219da 61 fields · synced May 17, 2026
  • EUDAMED 8a848d98-d865-4cd3-9a38-9982af2e1d15 61 fields · synced May 17, 2026
  • EUDAMED b6c1cb4c-c585-4dc6-85b3-dafd1dd3eb7b 61 fields · synced May 17, 2026
  • EUDAMED 2681aeba-0b4a-4661-90db-06a49b43dcb2 61 fields · synced May 17, 2026
  • EUDAMED 06197019-9ed5-4608-8047-47d93073c7c0 61 fields · synced May 17, 2026
  • EUDAMED 9f93ee4c-dfd2-4140-95b7-600a67201d3e 61 fields · synced May 17, 2026
  • EUDAMED e903f001-aa2e-496a-8b9c-430a5e49e70f 61 fields · synced May 18, 2026
  • EUDAMED 4d04c049-2f7e-4975-a67a-bb652bae71f7 61 fields · synced May 18, 2026
  • EUDAMED 3d1c8ec7-e71f-4a78-940f-33edd76d22f4 61 fields · synced May 18, 2026
  • EUDAMED 6bbf188a-2783-4d89-bec8-ffedefcb3137 61 fields · synced May 18, 2026
  • EUDAMED 4dce25ea-79b9-417d-8016-c0d004da0189 61 fields · synced May 18, 2026
  • EUDAMED 8ec5f765-543a-4429-b995-408700a1cd57 61 fields · synced May 19, 2026
  • EUDAMED 57cc4c40-c3ad-4007-aeb3-106f2f68854e 61 fields · synced May 19, 2026
  • EUDAMED d8f2ed5c-a52b-4eca-9921-b0b54b471234 61 fields · synced Jun 18, 2026
  • EUDAMED 7481e1ca-5df6-46d2-a10f-60b55d1911a1 61 fields · synced Jun 20, 2026
  • EUDAMED 61738ad8-ad01-44be-bf47-621116594c70 61 fields · synced Jul 9, 2026
  • EUDAMED 723a89d8-83ed-45fc-8623-58913a8a2196 61 fields · synced Jul 9, 2026
  • EUDAMED 68fe290d-3166-46b9-8a6f-19e2c8a80d77 61 fields · synced Jul 9, 2026
  • EUDAMED ac061c85-125c-44be-9039-c9024eb9cc65 61 fields · synced Jul 9, 2026
  • EUDAMED 56358e36-27f8-4e25-8841-f112393eeb8a 61 fields · synced Jul 10, 2026
  • EUDAMED ad8b785b-89bb-4595-97fc-09404c91e4ac 61 fields · synced Jul 10, 2026
  • EUDAMED 27278812-5622-410e-a20f-f266b8162aa1 61 fields · synced Jul 10, 2026
  • EUDAMED 0099b817-0bb4-4c06-a030-83cee95abd21 61 fields · synced Jul 11, 2026
  • EUDAMED 7edfc872-45cb-4b84-9bbd-88bd4a6e6287 61 fields · synced Jul 12, 2026
  • EUDAMED 2a00fd7c-fd6f-4a96-b174-0e144bd92de4 61 fields · synced Jul 12, 2026
  • EUDAMED beed13f7-d60a-4ba6-b546-1bad85f1a37c 61 fields · synced Jul 13, 2026
  • EUDAMED 9d80a408-3c7a-4118-8939-29bf5ed2f25d 61 fields · synced Jul 13, 2026
  • EUDAMED 39518036-ee84-488e-8fcb-c1c7a3427050 61 fields · synced Jul 13, 2026
  • EUDAMED 02ad0e51-0d5e-46df-8d64-ebd0c1666bc9 61 fields · synced Jul 15, 2026
  • EUDAMED 4c0a3c3b-cdb2-42e4-8091-6e18d1c05566 61 fields · synced Jul 17, 2026
  • EUDAMED b47bccdb-c1a9-4f6f-a0c7-bb159ee692d4 61 fields · synced Jul 19, 2026
  • EUDAMED 6a6371aa-9d0d-4814-a0a3-f7b358a1d4fd 61 fields · synced Jul 19, 2026
  • EUDAMED 8f09dc6c-56b0-4045-a306-cee8d457da25 61 fields · synced Jul 23, 2026
  • EUDAMED fc63f1f1-bae5-40d8-8b71-90e3ad5fb53a 61 fields · synced Jul 24, 2026
  • EUDAMED 4c3cd98e-67f6-47a4-a8ee-72bd00aa0fc0 61 fields · synced Jul 27, 2026
  • EUDAMED 7d6b3317-95ed-410a-a4ce-0e306093dffa 61 fields · synced Jul 28, 2026
  • EUDAMED af9564b6-3a12-45d2-9ec8-02825b52fccb 61 fields · synced Jul 29, 2026
  • EUDAMED 39965741-fa35-4382-a27c-f1050bc4c224 61 fields · synced Jul 30, 2026
  • EUDAMED bcc68bab-9e56-4f5f-9501-bec92aa9aed4 61 fields · synced Jul 31, 2026
  • EUDAMED 9bfecd78-6a62-4843-a230-22d4e58a84a7 61 fields · synced Jul 31, 2026
  • EUDAMED 0e5ea1af-718f-41be-8d09-7813e8c754c8 61 fields · synced Jul 31, 2026
  • EUDAMED ccf26293-37bc-47e5-9185-d8af83eaa178 61 fields · synced Aug 1, 2026
  • EUDAMED e9824939-231a-4b1b-bb0d-f04064e46c5d 61 fields · synced Aug 1, 2026
  • EUDAMED 939e7085-541f-4659-82ab-4b1f8b7e0b79 61 fields · synced Aug 2, 2026
  • EUDAMED 6ee08c7b-a853-4b6e-8c53-363c28af0bcb 61 fields · synced Sep 30, 2026