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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 851-870 of 870

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  • Surgical gowns Ref NM-100-301 DH-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref 75-0125-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Absorbent towels Ref 14-0101-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical gowns Ref 354543-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Pouches Ref 60-0101-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref 16553-F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Vascular interventional radiologic procedure pack Ref 501-197-S

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Surgical gowns Ref P-351053

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref NM-80-0157-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical gowns Ref 02 241

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref AR-108-074-11-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref 16085-F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref D71-0137-WB-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Fixation elements Ref 78-0105-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical gowns Ref 354523-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref ce105131-u

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref 80-0147-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref DH742

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Covers Ref 201-326-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Pouches Ref 60-0120-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

Rows 851-870 of 870

Showing 851-870 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.