BATIST Medical Productions s.r.o.

Certificate 24 0234 QR/NB

Rev. S1Supplemented

Valid until: Jun 25, 2029

Overview

Certificate number: 24 0234 QR/NB
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 102324 0234 QR/NBS1

Validity

Issued: Sep 15, 2025
Valid from: Sep 15, 2025
Valid until: Jun 25, 2029

Notified body

Notified body: INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390
Notified body SRN: 1023
Notified body country: Czechia

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

24 0234 QR/NBQuality management systemIssuedJun 26, 2024 → Jun 25, 2029

Scope coverage

Class I23

23 scopes

Sterile gauze products Sterile cellulose wadding Sterile drapes
Class I
Gauze compress sterile I.V.
Class I
Folded gauze cuttings with cellulose wadding
Class I
Cotton pad in gauze wrapping
Class I
BURN BANDAGE
Class I
Cellulose Wadding Tampon sterile
Class I
U drape with absorbent patch
Class I
Extremity drape
Class I
Vertical drape
Class I
Angiography drape
Class I
Ophthalmic drape
Class I
Laparoscopy drape
Class I
Utility drape
Class I
Adhesive utility drape
Class I
Utility drape with aperture
Class I
Adhesive utility drape with aperture
Class I
Stockinette
Class I
Arm cover
Class I
Legging
Class I
Dental drape
Class I

1 / 2

Documents

LanguagesCSEN

BATIST Medical Productions s.r.o.

Certificate 24 0234 QR/NB

Rev. S1Supplemented

Valid until: Jun 25, 2029

Overview

Certificate number: 24 0234 QR/NB
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 102324 0234 QR/NBS1

Validity

Issued: Sep 15, 2025
Valid from: Sep 15, 2025
Valid until: Jun 25, 2029

Manufacturer

Manufacturer: BATIST Medical Productions s.r.o.
Manufacturer SRN: CZ-MF-000023495
Manufacturer country: Czechia

Notified body

Notified body: INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390
Notified body SRN: 1023
Notified body country: Czechia

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

24 0234 QR/NBQuality management systemIssuedJun 26, 2024 → Jun 25, 2029

Scope coverage

Class I23

23 scopes

Sterile gauze products Sterile cellulose wadding Sterile drapes
Class I
Gauze compress sterile I.V.
Class I
Folded gauze cuttings with cellulose wadding
Class I
Cotton pad in gauze wrapping
Class I
BURN BANDAGE
Class I
Cellulose Wadding Tampon sterile
Class I
U drape with absorbent patch
Class I
Extremity drape
Class I
Vertical drape
Class I
Angiography drape
Class I
Ophthalmic drape
Class I
Laparoscopy drape
Class I
Utility drape
Class I
Adhesive utility drape
Class I
Utility drape with aperture
Class I
Adhesive utility drape with aperture
Class I
Stockinette
Class I
Arm cover
Class I
Legging
Class I
Dental drape
Class I

1 / 2

Documents

LanguagesCSEN