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Kp-3506-31

by Guilin Kevin Peter Technology Co., Ltd.

Ref /Model KP,DM: 1006, 1008, 12vt, 1302, 1403, 1506, 1602, 1603, 1606, 16vt, 1704, 1705, 1708, 1712, 1805, 1902, 2004, 2005, 2006, 2007, 2205, 2206, 2504, 2506, 2508, 3002, 3004, 3006, 3009, 3502, 3504, 3506, 4002, 4004, 4006, 4502, 4503, 4504, 5002, 5004, 6002, E

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06975384334789 UDI-DI Date30 Dec 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number69753843302YN Basic UDI-DI 06975384334789UDI-DIDate11 Jul 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Kp-3506-31 EUDAMED
Kp GUDID
Generic Name
Rotary/reciprocating endodontic file/rasp, reusable
Device Name
Root Canal File
Model / Reference
KP EUDAMED
DM: 1006 EUDAMED
1008 EUDAMED
12vt EUDAMED
1302 EUDAMED
1403 EUDAMED
1506 EUDAMED
1602 EUDAMED
1603 EUDAMED
1606 EUDAMED
16vt EUDAMED
1704 EUDAMED
1705 EUDAMED
1708 EUDAMED
1712 EUDAMED
1805 EUDAMED
1902 EUDAMED
2004 EUDAMED
2005 EUDAMED
2006 EUDAMED
2007 EUDAMED
2205 EUDAMED
2206 EUDAMED
2504 EUDAMED
2506 EUDAMED
2508 EUDAMED
3002 EUDAMED
3004 EUDAMED
3006 EUDAMED
3009 EUDAMED
3502 EUDAMED
3504 EUDAMED
3506 EUDAMED
4002 EUDAMED
4004 EUDAMED
4006 EUDAMED
4502 EUDAMED
4503 EUDAMED
4504 EUDAMED
5002 EUDAMED
5004 EUDAMED
6002 EUDAMED
E EUDAMED
/ EUDAMED
KP-3506-31 GUDID
Primary DI / UDI-DI
06975384334789
Basic UDI-DI
69753843302YN
FDA Product Code
EKS
EMDN Code
L159004 Endodontic rasps and files, reusable
GMDN Term
Rotary/reciprocating endodontic file/rasp, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.4565
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
CN-MF-000022934
Authorised representative
MedNet EC-REP C IIb GmbH DE-AR-000011194

Related devices

Category: Manual endodontic file/rasp, reusable

Other devices from Guilin Kevin Peter Technology Co., Ltd.

See all devices from Guilin Kevin Peter Technology Co., Ltd. →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No