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K Flex

EUDAMED

Class IIa (EU MDR)

Ref ZKFLEX2520Model K Flex 25mm 20 (6 units)Ref ZKX31ASST1Model K Flex 31mm 15-40 (6 units)Ref ZKFLEX2130Model K Flex 21mm 30 (6 units)Ref ZKX31ASST2Model K Flex 31mm 45-80 (6 units)Ref ZKFLEX3155Model K Flex 31mm 55 (6 units)Ref ZKFLEX2545Model K Flex 25mm 45 (6 units)Ref ZKX25ASST2Model K Flex 25mm 45-80 (6 units)Ref ZKFLEX3125Model K Flex 31mm 25 (6 units)Ref ZKFLEX2580Model K Flex 25mm 80 (6 units)Ref ZKFLEX2135Model K Flex 21mm 35 (6 units)Ref ZKFLEX2160Model K Flex 21mm 60 (6 units)Ref ZKFLEX2570Model K Flex 25mm 70 (6 units)Ref ZKFLEX2150Model K Flex 21mm 50 (6 units)Ref ZKFLEX3160Model K Flex 31mm 60 (6 units)Ref ZKFLEX2125Model K Flex 21mm 25 (6 units)Ref ZKFLEX2140Model K Flex 21mm 40 (6 units)Ref ZKFLEX2115Model K Flex 21mm 15 (6 units)Ref ZKFLEX3145Model K Flex 31mm 45 (6 units)Ref ZKFLEX2170Model K Flex 21mm 70 (6 units)Ref ZKX21ASST2Model K Flex 21mm 45-80 (6 units)Ref ZKFLEX2155Model K Flex 21mm 55 (6 units)Ref ZKFLEX2525Model K Flex 25mm 25 (6 units)Ref ZKFLEX2530Model K Flex 25mm 30 (6 units)

by Shenzhen Denco Medical Co., Ltd.

Identity

Trade Name
K Flex EUDAMED
Model / Reference
K Flex 25mm 20 (6 units) EUDAMED
ZKFLEX2520 EUDAMED
K Flex 31mm 15-40 (6 units) EUDAMED
ZKX31ASST1 EUDAMED
K Flex 21mm 30 (6 units) EUDAMED
ZKFLEX2130 EUDAMED
K Flex 31mm 45-80 (6 units) EUDAMED
ZKX31ASST2 EUDAMED
K Flex 31mm 55 (6 units) EUDAMED
ZKFLEX3155 EUDAMED
K Flex 25mm 45 (6 units) EUDAMED
ZKFLEX2545 EUDAMED
K Flex 25mm 45-80 (6 units) EUDAMED
ZKX25ASST2 EUDAMED
K Flex 31mm 25 (6 units) EUDAMED
ZKFLEX3125 EUDAMED
K Flex 25mm 80 (6 units) EUDAMED
ZKFLEX2580 EUDAMED
K Flex 21mm 35 (6 units) EUDAMED
ZKFLEX2135 EUDAMED
K Flex 21mm 60 (6 units) EUDAMED
ZKFLEX2160 EUDAMED
K Flex 25mm 70 (6 units) EUDAMED
ZKFLEX2570 EUDAMED
K Flex 21mm 50 (6 units) EUDAMED
ZKFLEX2150 EUDAMED
K Flex 31mm 60 (6 units) EUDAMED
ZKFLEX3160 EUDAMED
K Flex 21mm 25 (6 units) EUDAMED
ZKFLEX2125 EUDAMED
K Flex 21mm 40 (6 units) EUDAMED
ZKFLEX2140 EUDAMED
K Flex 21mm 15 (6 units) EUDAMED
ZKFLEX2115 EUDAMED
K Flex 31mm 45 (6 units) EUDAMED
ZKFLEX3145 EUDAMED
K Flex 21mm 70 (6 units) EUDAMED
ZKFLEX2170 EUDAMED
K Flex 21mm 45-80 (6 units) EUDAMED
ZKX21ASST2 EUDAMED
K Flex 21mm 55 (6 units) EUDAMED
ZKFLEX2155 EUDAMED
K Flex 25mm 25 (6 units) EUDAMED
ZKFLEX2525 EUDAMED
K Flex 25mm 30 (6 units) EUDAMED
ZKFLEX2530 EUDAMED

Identifiers

Primary DI / UDI-DI
06975718051368 EUDAMED
06975718051511 EUDAMED
06975718051290 EUDAMED
06975718051528 EUDAMED
06942512501740 EUDAMED
06975718051412 EUDAMED
06975718051436 EUDAMED
06975718051467 EUDAMED
06942512501726 EUDAMED
06975718051306 EUDAMED
06942512501658 EUDAMED
06942512501719 EUDAMED
06942512501634 EUDAMED
06942512501757 EUDAMED
06975718051283 EUDAMED
06975718051313 EUDAMED
06975718051269 EUDAMED
06975718051504 EUDAMED
06942512501665 EUDAMED
06975718051344 EUDAMED
06942512501641 EUDAMED
06975718051375 EUDAMED
06975718051382 EUDAMED
Basic UDI-DI
B-06975718051368 EUDAMED
B-06975718051511 EUDAMED
B-06975718051290 EUDAMED
B-06975718051528 EUDAMED
B-06942512501740 EUDAMED
B-06975718051412 EUDAMED
B-06975718051436 EUDAMED
B-06975718051467 EUDAMED
B-06942512501726 EUDAMED
B-06975718051306 EUDAMED
B-06942512501658 EUDAMED
B-06942512501719 EUDAMED
B-06942512501634 EUDAMED
B-06942512501757 EUDAMED
B-06975718051283 EUDAMED
B-06975718051313 EUDAMED
B-06975718051269 EUDAMED
B-06975718051504 EUDAMED
B-06942512501665 EUDAMED
B-06975718051344 EUDAMED
B-06942512501641 EUDAMED
B-06975718051375 EUDAMED
B-06975718051382 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

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

K Flex 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 (23)

  • EUDAMED add9bec4-9aa7-450d-affc-ddcdc92a8f5e 61 fields · synced Aug 4, 2026
  • EUDAMED 0405b8ef-e75f-4a09-a08e-7f6f32dc3cfb 61 fields · synced May 11, 2026
  • EUDAMED 0904e9d4-aea9-4f29-9c63-3d9842f57430 61 fields · synced May 11, 2026
  • EUDAMED d26afb67-a68b-417d-a085-864df7c04f65 61 fields · synced May 16, 2026
  • EUDAMED 72a4f42c-d5e8-4ee1-a9d7-c7c07691bbcd 61 fields · synced May 16, 2026
  • EUDAMED c48a4523-072f-42e3-a1f1-7d5c16c404a7 61 fields · synced May 16, 2026
  • EUDAMED b81b7007-83a1-4080-87ee-f4952fc0278e 61 fields · synced May 16, 2026
  • EUDAMED d3055767-b37d-4eeb-8e00-707f36f3b577 61 fields · synced May 17, 2026
  • EUDAMED 70ba5ce5-8080-4963-b590-0d702c698c62 61 fields · synced May 17, 2026
  • EUDAMED fc623550-ac67-46ce-bf5f-3c2c1911bbcb 61 fields · synced May 17, 2026
  • EUDAMED 9c6161f6-6624-4fa3-9a50-53261950f984 61 fields · synced May 17, 2026
  • EUDAMED 11e17d4c-8eea-4077-b23e-7cf116a44701 61 fields · synced May 17, 2026
  • EUDAMED 23d01fec-7e39-4ff0-9711-14c8e7177dac 61 fields · synced May 17, 2026
  • EUDAMED bc0bb336-d57b-46bf-a033-b8f90a949b9b 61 fields · synced May 17, 2026
  • EUDAMED 790b253c-83de-4753-a983-0ccf84e89f64 61 fields · synced May 18, 2026
  • EUDAMED 473cd68b-4245-4308-b873-f1095fa36a84 61 fields · synced May 18, 2026
  • EUDAMED b3f73717-4f3a-4f9f-844b-3d816cb2a91e 61 fields · synced May 18, 2026
  • EUDAMED aee17168-8ed5-4d94-a661-187335013eee 61 fields · synced May 18, 2026
  • EUDAMED 5f4d3bf7-a6d3-44cb-b35e-a1722cb3403d 61 fields · synced May 18, 2026
  • EUDAMED 087c72bb-c980-4707-8cce-30ef1ebff5f5 61 fields · synced May 18, 2026
  • EUDAMED 8422f65e-d511-4bd4-aacd-8c085505027d 61 fields · synced May 18, 2026
  • EUDAMED 6de185f3-db39-42e2-a03d-a4eebb151f54 61 fields · synced May 18, 2026
  • EUDAMED 2b052130-ec73-44fa-bdab-1385904a1924 61 fields · synced May 18, 2026