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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 401-450 of 870

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  • Vascular procedure pack Ref 40-15-054-S

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Surgical drapes Ref DH550

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH412

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref P-20-0104-HH

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref 75-0108-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref AR-103-067-15-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH733

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 50995

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref 75-0101-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 080449

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Caps Ref 15902

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref AR-501-008-11-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 301-664-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 301-164-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Other procedure pack Ref 40-10-037-S

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Surgical drapes Ref 201-294-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref XDGNR03

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 302-003-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 17977-F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 081332

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Pouches Ref 60-0101-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 501-232-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 10875-F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref 50987

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref MED-201-030-26-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical gowns Ref 354563-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 10826-F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 301-617-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref 71-0125-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical gowns Ref P-354533

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Fixation elements Ref 70-0125-I-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 701-206-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref AR-502-083-11-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref AR-103-019-20-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Caps Ref 15510

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref MED-201-007-26-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 10-0103-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 20-0255-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref NM-100-464 DH-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DZ-15703-002

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref DH054

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 701-160-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Caps Ref 15510 DH

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Colonoscopy shorts Ref 69223

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref NM-100-405 DH-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 17859-F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref 50985

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical gowns Ref 354573-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Caps Ref 16624 DH

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Caps Ref 11451-F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

Rows 401-450 of 870

Showing 401-450 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.