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DINA – HITEX, spol. s r.o.

Active in EUDAMED

Czechiafrom SRN EUDAMED FDA SRN CZ-MF-000000312

Devices
870
Registrations
EUDAMEDFDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

EU certificates

7 of 7 in force.

See certificates

Market reach

European Union
EUDAMED actor, 7 certificates
United States
FDA establishment

Catalogue870

Newest first, rows 1-50 of 870

Search and filter all 870 devices
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  • Covers Ref 31940

    Class I
    Active CE MDR EUDAMED I

  • Covers Ref DH160

    Class I
    Active CE MDR EUDAMED I

  • Surgical drapes Ref DH416

    Class I
    Active CE MDR EUDAMED I

  • Surgical drapes Ref 17548-F

    Class I
    Active CE MDR EUDAMED I

  • Surgical drapes Ref 18507-F

    Class I
    Active CE MDR EUDAMED I

  • Surgical drapes Ref 17549-F

    Class I
    Active CE MDR EUDAMED I

  • Surgical drapes Ref 10-0102-P

    Class I
    Active CE MDR EUDAMED I

  • Surgical drapes Ref 11420-F

    Class I
    Active CE MDR EUDAMED I

  • Covers Ref 50988

    Class I
    Active CE MDR EUDAMED I

  • Surgical drapes Ref 18458-F

    Class I
    Active CE MDR EUDAMED I

  • Covers Ref 71-0108-S

    Class I
    Active CE MDR EUDAMED I

  • Surgical drapes Ref AR-102-012-17-P

    Class I
    Active CE MDR EUDAMED I

  • Surgical drapes Ref 03078

    Class I
    Active CE MDR EUDAMED I

  • Surgical drapes Ref 301-159-S

    Class I
    Active CE MDR EUDAMED I

  • Caps Ref 14522 DH

    Class I
    Active CE MDR EUDAMED I

  • Surgical gowns Ref 354523-I-S

    Class I
    Active CE MDR EUDAMED I

  • Vascular procedure pack Ref 40-06-013-S

    Class IIb
    Active CE MDR EUDAMED IIb

  • Surgical drapes Ref DZ-24730-002

    Class I
    Active CE MDR EUDAMED I

  • Fixation elements Ref 78-0101-P

    Class I
    Active CE MDR EUDAMED I

  • Covers Ref 40-2005-P

    Class I
    Active CE MDR EUDAMED I

  • Covers Ref 40-0101-P

    Class I
    Active CE MDR EUDAMED I

  • Surgical drapes Ref MED-201-004-26-P

    Class I
    Active CE MDR EUDAMED I

  • Surgical drapes Ref XDFNR02

    Class I
    Active CE MDR EUDAMED I

  • Pouches Ref 60-0103-P

    Class I
    Active CE MDR EUDAMED I

  • Surgical drapes Ref 11485-F

    Class I
    Active CE MDR EUDAMED I

  • Surgical drapes Ref DH109

    Class I
    Active CE MDR EUDAMED I

  • Surgical gowns Ref 354543-I-S

    Class I
    Active CE MDR EUDAMED I

  • Surgical drapes Ref 301-198-S

    Class I
    Active CE MDR EUDAMED I

  • Surgical drapes Ref DH611

    Class I
    Active CE MDR EUDAMED I

  • Fixation elements Ref 70-0116-P

    Class I
    Active CE MDR EUDAMED I

  • Covers Ref 40-0218-P

    Class I
    Active CE MDR EUDAMED I

  • Absorbent towels Ref 96912 DH-P

    Class I
    Active CE MDR EUDAMED I

  • Pouches Ref DH698

    Class I
    Active CE MDR EUDAMED I

  • Surgical drapes Ref 40958

    Class I
    Active CE MDR EUDAMED I

  • Surgical gowns Ref 351023-I-S

    Class I
    Active CE MDR EUDAMED I

  • Surgical drapes Ref MED-201-021-26-P

    Class I
    Active CE MDR EUDAMED I

  • Covers Ref 80-0119-S

    Class I
    Active CE MDR EUDAMED I

  • Covers Ref 71-1602-S

    Class I
    Active CE MDR EUDAMED I

  • Surgical gowns - reinforced Ref 350153-S

    Class I
    Active CE MDR EUDAMED I

  • Surgical drapes Ref MED-201-008-26-P

    Class I
    Active CE MDR EUDAMED I

  • Surgical drapes Ref 50-0702-P

    Class I
    Active CE MDR EUDAMED I

  • Surgical gowns - reinforced Ref 354653-S

    Class I
    Active CE MDR EUDAMED I

  • Covers Ref 71-0117-S

    Class I
    Active CE MDR EUDAMED I

  • Surgical drapes Ref 50-0201-P

    Class I
    Active CE MDR EUDAMED I

  • Surgical drapes Ref 301-507-S

    Class I
    Active CE MDR EUDAMED I

  • Covers Ref 50993

    Class I
    Active CE MDR EUDAMED I

  • Absorbent towels Ref 96903 DH

    Class I
    Active CE MDR EUDAMED I

  • Surgical drapes Ref 11746-F

    Class I
    Active CE MDR EUDAMED I

  • Surgical drapes Ref DH718

    Class I
    Active CE MDR EUDAMED I

  • Surgical drapes Ref 10773-F

    Class I
    Active CE MDR EUDAMED I

Rows 1-50 of 870

Showing 1-50 of 870

Company details

EUDAMED SRN
CZ-MF-000000312
SRN (system / procedure pack)
CZ-PR-000000561
EU VAT number
CZ 469 65 661
EUDAMED status
Active
EUDAMED registered name
DINA – HITEX, spol. s r.o.
Registered address
987, Ždánská, 68501, Bučovice, Czechia
PRRC contact
Shashidhar Singh(public in EUDAMED)

EUDAMED certificates7

7 certificates7 valid, 0 expiredMDR 7next expiry 10 Nov 2028

EUDAMED certificates (7)

3EC International a.s. 2265 7 certificates

  • 2023-MDR/QS-044 Issued

    Quality management system EU MDR

    Issued
    10 Nov 2023
    Expires
    10 Nov 2028
  • 2023-MDR/QS-049 Issued

    Quality management system EU MDR

    Issued
    10 Nov 2023
    Expires
    10 Nov 2028
  • 2023-MDR/QS-050 Issued

    Quality management system EU MDR

    Issued
    10 Nov 2023
    Expires
    10 Nov 2028
  • 2023-MDR/QS-051 Issued

    Quality management system EU MDR

    Issued
    10 Nov 2023
    Expires
    10 Nov 2028
  • 2023-MDR/QS-052 Issued

    Quality management system EU MDR

    Issued
    10 Nov 2023
    Expires
    10 Nov 2028
  • 2023-MDR/QS-053 Amended

    Quality management system EU MDR

    Issued
    9 Sep 2025
    Expires
    10 Nov 2028
    Reason
    Other
  • 2023-MDR/QS-054 Amended

    Quality management system EU MDR

    Issued
    20 Mar 2025
    Expires
    10 Nov 2028
    Reason
    Mnf data change

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • DINA-HITEX, spol. s r.o. Bucovice Vyskov · CZ FEI 3003767927

From the company website

Read 18 Oct 2026

We are DINA-HITEX, Czech leader in the production of disposable medical materials. We specialize in the production of complex operating covers and operating sets.

Translated from the manufacturer's own website. Source

Frequently asked questions

How many devices does DINA – HITEX, spol. s r.o. have in the registry?

The registry currently lists 870 devices for DINA – HITEX, spol. s r.o.. Devices recorded under merged duplicate company entries are counted once.

Which registries list DINA – HITEX, spol. s r.o.'s devices?

Among its 50 most recently registered devices, DINA – HITEX, spol. s r.o. has devices listed in EUDAMED (50 devices).

What risk classes do DINA – HITEX, spol. s r.o.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for DINA – HITEX, spol. s r.o.'s devices are Class I and Class IIb. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for DINA – HITEX, spol. s r.o.?

EUDAMED lists 7 certificates for DINA – HITEX, spol. s r.o. (quality management system) under MDR. 5 are recorded with the status issued. The most recent was issued on 2025-09-09.

What are the newest devices from DINA – HITEX, spol. s r.o. in the registry?

The most recently registered devices listed for DINA – HITEX, spol. s r.o. include Covers, Surgical drapes, Caps and Surgical gowns.

Which FDA establishments are linked to DINA – HITEX, spol. s r.o.?

1 FDA establishment is linked to DINA – HITEX, spol. s r.o. in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.