Skip to content

DINA – HITEX, spol. s r.o.

Active in EUDAMED

Czechiafrom SRN EUDAMED FDA SRN CZ-MF-000000312

Devices
870
Registrations
EUDAMEDFDA
FDA recalls
0

Catalogue870

Newest first, rows 51-100 of 870

Search and filter all 870 devices
Skip device list

  • Surgical drapes Ref AR-103-020-11-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Procedure pack for general surgery Ref 102-194-S

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Surgical gowns Ref 350053-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • ENT procedure pack Ref 106-061-S

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Surgical drapes Ref MED-201-015-26-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref 75-0110-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Caps Ref 14212

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH608

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref MED-201-012-26-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH710

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH604

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 301-509-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Scrubs Ref 67493

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical gowns - reinforced Ref P-351143

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 27-0420-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref V-108-002-26-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref MED-201-034-26-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref 31941

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Orthopaedics procedure pack Ref 301-233-S

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Surgical drapes Ref 20-0401-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH425

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref MED-101-001-26-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 50801-SMS-HH

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref NR-201-008-26-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Scrubs Ref 66943

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref AR-103-059-16-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 080552MS

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 50-0219-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 20-0116-AP

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 11504-F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH852

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Caps Ref 14512 DH

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 10-0112-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref NM-100-402 DH-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref 80-0103-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical gowns - reinforced Ref 354633-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 501-222-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 301-284-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref AR-108-051-16-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 592-001-26-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH449

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 302-112-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref AR-501-013-11-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref 80-0151-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH857

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 15-0403-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref 31961

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Caps Ref 14912

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Fixation elements Ref 70-0136-2-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 701-127-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

Rows 51-100 of 870

Showing 51-100 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 Active

    Quality management system EU MDR

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

    Quality management system EU MDR

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

    Quality management system EU MDR

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

    Quality management system EU MDR

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

    Quality management system EU MDR

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

    Quality management system EU MDR

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

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 9 Sep 2025.

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.