MDR

Dokumenty ke stažení

MDR - Typ a klasifikace výrobků
MDR typ a klasifikace výrobku CZ_vysvětlivky
HARTMANN Prohlášení o shodě dle MDR
Prohlášení o shodě u jednotlivých produktů naleznete v sekci produkty v části: Ke stažení.
HARTMANN Prohlášení o shodě dle MDD

EC_Declaration_of_Conformity_MD_class_I_sterile_PHAG_2021_02_25

EC_Declaration_of_Conformity_MD_class_IIa-IIb-III_PHAG_2021_02_25

HARTMANN EC certifikáty

Certificate G100118580065MDRIIaIIbRev 04enPHAG

Certificate G120118580076MDRIIIRev 00enPHAG

Certificate G210118580069MDRI sterilRev 05ENCZ

Certificate G210118580069MDRI sterilRev 05enPHAG

Certificate G240118580072 Rev 02en

Certificate G240118580072 Rev 02ENCZ

Certificate G260118580077 Rev 00Class Is valid from 301125

G70011858 0073Rev 00ePHAG

MDR Statement of System and Procedure Pack 2026-08-14

HARTMANN-RICO Prohlášení o shodě dle MDR

DoCMDR1014 Vložky porodnické CZ

DoCMDR1899 PrubanCZ

DoCMDR2340 ARACZ

DoCMDR2586 Obvazová gáza skládanáCZ

DoCMDR2588 Obvazová gáza v přířezechCZ

HARTMANN-RICO Prohlášení o shodě dle MDD
PoS_HR_Is_platny do 2024
HARTMANN-RICO EC certifikáty
EC Certifikát HARTMANN-RICO_CZ
BODE Prohlášení o shodě dle MDR

2026-02-13-BODE X-Wipes-EU Declaration of Conformity-MDR

2027-10-15-Bacillol 30 Sensitive Tissues-EU Declaration of Conformity-MDR

2027-10-16-Bacillol 30 Sensitive Foam_EU Declaration of Conformity-MDR

2027-10-21-Bacillol AF-EU Declaration of Conformity-MDR

2027-10-21-Bacillol Tissues-EU Declaration of Conformity-MDR

2027-10-21-Mikrobac forte-EU Declaration of Conformity-MDR

2027-10-21-Mikrobac Tissues-EU Declaration of Conformity-MDR

2027-10-23-Dismozon plus-EU Declaration of Conformity-MDR

2027-10-23-Korsolex basic-EU Declaration of Conformity-MDR (1)

2027-11-06-Bomix plus-EU Declaration of Conformity-MDR

2027-11-06-Mikrobac Virucididal Tissues-EU Declaration of Conformity-MDR

2027-11-13-Bacillol Oxy Tissues-EU Declaration of Conformity-MDR

2027-11-13-Bacillol Zero Tissues-EU Declaration of Conformity-MDR

BODE Prohlášení o shodě dle MDD

Mikrobac plus Prisman:

Annex VIII CE 237Bode Chemie GmbH Rev00

EC_DoC_Prisman_Virex_plus_Mikrobac_plus

BODE EC certifikáty

EC Certifikát MEDCERT_13_11_2025

2030_11_12_CERT_0523GB44825101_BODE

Mikrobac plus Prisman:

EG_Zertifikat 93_42_EWG Anhang II und Anhang V

DANSAC Prohlášení o shodě dle MDR

07694_version_4_Dansac_MDR_DOC_2_Piece_Ostomy_Pouches_Barriers

07695_version_3_Dansac_MDR_DOC_1_Piece_Ostomy_Pouches

07701version2DansacMDRDOC Night drainage bags Belts and Clamps

07706_version_2_Dansac_MDR_DOC_Ostomy_Accessories

Veroval IVD

Care Diagnostica urine chlamydie:

DoC Stomach Prevention valid with Extension letter of Notified body

EC Cert_ Care diagnostica_98_79_certificate_D4002000016_Exp_2025-05-26 plus Confirmation letter QMD

extended DoC Veroval self-tests Care Diagnostica_exp_ 20271231

Extension of EC certificate NanoRepro

NanoRepro ferritin gluten heli:

DoC Ferritin Check valid with Extension letter of Notified body

DoC Gluten intolerance valid with Extension letter of Notified body

DoC Stomach Prevention valid with Extension letter of Notified body

Extension of EC certificate NanoRepro

Veroval Diagnostika dle MDR

Insect bite healer

Bite Gone CH3000_EC Declaration of Conformity

FI23_0000008_Certificate-Sz_Dongdixin-EU-QMS-2023-03-21

Veroval BPM upper arm

Globalcare_MDR Certificate

Veroval BPM upper arm_Globalcare_GCE604 EC DoC 20230207

Veroval compact BPU22

Globalcare_MDR Certificate

Veroval Compact BPU22_GlobalCare_DoC_20240708

Veroval compact BPU26

Globalcare_MDR Certificate

Veroval Compact BPU26_Globalcare_EC DoC 20240708

Veroval compact BPW26

Avita EU Certificate MDR 775622

Veroval compact BPW26_Avita_DoC_BPW26_BPM27B_20230322_APQ0-19-060

Veroval duo control

DoC_Veroval Duo Control_MDR-RED_2259_9255043_9255243

MDRG10 011858 0065Rev 04IIaIIb valid from 06052025 05052030

Veroval ECG BPM

DoC_Veroval EKG_20200603_9253470

Veroval wrist BPM

Avita EU Certificate MDR 775622

Veroval wrist BPM_Avita_OEM_DoC_20200301_MDD

Ostatní Prohlášení o shodě dle MDR

DoC MDR_Cobes Industries_Foliodress surgical Gowns

DoC MDR_TENA Comfort 2021-01

DoC MDR_TENA Comfort 2021-02

DoC MDR_TENA Fflex

DoC MDR_TENA FIX

DoC MDR_TENA Flex 2021-01

DoC MDR_TENA lady

DoC MDR_TENA lady pants

DoC MDR_TENA MEN

DoC MDR_TENA Men 2021-01

DoC MDR_TENA Pants Unisex 2021-03

DoC MDR_TENA Pants Unisex 2021-04

DoC MDR_TENA podlozky

DoC MDR_TENA Slip 2021-01

DoC MDR_TENA Slip 2021-02

DoC MDR_Verba

Ostatní Prohlášení o shodě dle MDD

DoC MDD_Acto_Hydroclean solution

DoC MDD_Acto_Preventia

Ostatní certifikáty

Certificate G10 083478 0030_Zhejiang Longterm_Viverex Silikonové krytí

Certifikat MDD_Acto

Certifikat MDR_Cobes Industries_Foliodress surgical Gowns

ISO certifikáty

HARTMANNRICO as Certifikat SPD pro distributora leciv Tuchomerice2023

HARTMANNRICO as Certifikát SVP pro výrobce2025

ISO 111351SUP 031736 0013 Rev 04 valid 20251001 to 20280930

ISO 13485Q5 031736 0012 Rev05valid from 20251001 until 20280930

ISO 9001_1210015467 TMS_valid from 2025-10-01 until 2028-09-30