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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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  • MD Atlas
  • Shenzhen Denco Medical Co., Ltd.

Data from EUDAMED, last updated Jun 11, 2026

NITI H-Files

B-06970514915524

1 reference

Class IIa
Applicable legislation
MDD [Directive 93/42/EEC on medical devices]
Risk category
Class IIa
Manufacturer
Shenzhen Denco Medical Co., Ltd.

Device family identification

Device name
NITI H-Files
Basic UDI-DI
B-06970514915524
Device model
NITI H-Files 21mm #15-40 6pcs/pack
Issuing agency
EUDAMED
Version date
May 11, 2026

Classification

Applicable legislation
MDD [Directive 93/42/EEC on medical devices]
Risk category
Class IIa
Status
On the market

Manufacturer & authorised representative

Manufacturer

Name
Shenzhen Denco Medical Co., Ltd.
SRN
CN-MF-000014271
Country
China
Email
admin@chinacodent.com
Phone
+86 755 23764065

Authorised representative

Name
Share info GmbH
SRN
DE-AR-000005132
Country
Germany
Phone
+49 01795666508

Device characteristics

No device characteristics flagged

EMDN code(s)

European Medical Device Nomenclature — the EU product classifications carried across this device family's references.

  • Q010507Endodontic instruments (canal enlargers, files, rasps, etc.), single-use

References by status

Legacy certificates

Certificate number
DD60147804001
Type
refdata.legacy.mdd-certificate-type.v
Notified body
TÜV Rheinland LGA Products GmbH (0197)
Validity
Dec 31, 2028

References

1 reference

Export results

Applied filters

  • basicUdiUlid·01KRB6TA14YSPCM7TFXF62DPH9

Format

Summary

31 columns included
  • Trade name
  • Basic UDI-DI
  • UDI-DI code
  • Risk category
  • Applicable legislation
  • Status
  • Organization name
  • SRN
  • Reference / catalog number
  • Additional product description
  • Intended medical purpose
  • Market country
  • Issuing entity
  • Market info update date
  • Sterile
  • Single use
  • Contains latex
  • Reprocessed single-use
  • Direct marking
  • CMR substance
  • Endocrine disruptor
  • Annex XVI applicable
  • Sterilization
  • OEM applicable
  • EMDN codes
  • Last updated
  • Basic UDI-DI device name
  • Basic UDI-DI device model
  • Basic UDI-DI implantable
  • Basic UDI-DI reagent
  • DM Atlas link
Trade nameReference / catalog numberUDI-DI codeQuantityStatus
NITI H-FilesD-P.03.02-021-02-0A0-SR-000-00-00069705149155241On the market