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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

Catalogue870

Newest first, rows 451-500 of 870

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  • Surgical drapes Ref 20-0201-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Caps Ref 17344

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref MED-201-032-26-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 17516-F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH854

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Caps Ref 15912

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Pouches Ref 60-0124-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH604S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Caps Ref 13520

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 30-0456-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 201-283-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref MED-201-022-26-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref 40-0318-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref 80-0103-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Colonoscopy shorts Ref KH-7

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 201-101-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 301-641-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 701-178-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 201-258-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref MED-201-029-26-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Pouches Ref 60-0148-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 2310-019-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH316

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH837

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 10884-F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 301-152-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 03040

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH771

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 201-350-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 20-0133-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref AR-103-057-17-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref AR-502-036-11-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH758

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DZ-06200-001

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 301-513-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 104-128-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref MED-201-031-26-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref CM123435

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref V-103-002-26-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 11-0193-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 10-0101-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 10780-F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 201-539-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 10722-F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 21-0204-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 51701

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 104-146-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 10893-F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref NR-201-003-26-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 18355-F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

Rows 451-500 of 870

Showing 451-500 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.