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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 651-700 of 870

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  • Surgical drapes Ref 10-0132-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 40951

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref MED-201-010-26-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref AR-502-058-13-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 701-153-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 18468-F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 11769-F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref P-11-0102-HH

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 11492-F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 201-264-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 302-109-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Colonoscopy shorts Ref 46252

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref NM-100-403 DH-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref AR-502-015-11-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 51717-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 104-138-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref AR-502-077-11-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref XDGRR02

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 16554-F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DZ-45703-011

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH238

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref MED-201-020-26-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 18389-F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 501-253-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 11557-1

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref MED-201-024-26-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH216

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH577

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 301-635-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 201-209-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 11593-1

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref NM-100-401 DH-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref AR-501-006-11-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 11673-F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref AR-102-013-22-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH194

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH188

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 50-0202-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 2310-492-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 2318-013-S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 15-0404-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref DH849

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref MED-201-023-26-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Caps Ref 17314

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 20-0204-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Vascular procedure pack Ref 303-142-S

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Surgical drapes Ref 501-246-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref 51705-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref AR-501-008-20-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Surgical drapes Ref V-301-001-26-P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

Rows 651-700 of 870

Showing 651-700 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.