MDR - Typ a klasifikace výrobků

MDR typ a klasifikace výrobku CZ_vysvětlivky

Dokumenty - prohlášení o shodě a certifikáty

HARTMANN Prohlášení o shodě dle MDR

EN_PoS PHAG_I_konsolidovane
EN_PoS PHAG_IIa_IIb_III_konsolidovane
EN_PoS PHAG_Is_konsolidovane

HARTMANN Prohlášení o shodě dle MDD

EC_Declaration_of_Conformity_MD_class_I_PHAG_2021_01_11
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

G1_011858_0064_Rev.01_e
G1_011858_0064_Rev.01_e_attachment
G2S_011858_0063_Rev.00_e
G2S_011858_0063_Rev.00_e_supplement
G7_011858_0068_Rev.00_e
MDR G21 011858 0069_Rev.01_I sterilni

HARTMANN-RICO EC certifikáty

EC Certifikát HARTMANN-RICO_CZ

HARTMANN-RICO Prohlášení o shodě dle MDD

PoS_HR_Is_platny do 2024

HARTMANN-RICO Prohlášení o shodě dle MDR

DoC_MDR_1014 (Vložky porodnické)_CZ
DoC_MDR_1899 (Pruban)_CZ
DoC_MDR_2340 (ARA)_CZ
DoC_MDR_2586 (Obvazová gáza skládaná)_CZ
DoC_MDR_2588 (Obvazová gáza v přířezech)_CZ

BODE EC Certifikáty

EC Certifikát MEDCERT_13_11_2025
MEDCERT 93_42_EEC_EN_2023

BODE Prohlášení o shodě dle MDD

Bacillol 30 Foam 2021-11-16-EU-Declaration of Conformity MDD
Bacillol 30 Tissues 2021-11-16-EU-Declaration of Conformity MDD
Bacillol AF 2021-11-16-EU-Declaration of Conformity MDD
Bacillol Tissues 2021-11-16-EU-Declaration of Conformity MDD
Dismozon plus 2021-11-16-EC-Declaration of Conformity MDD
Mikrobac forte 2021-11-16-EU-Declaration of Conformity MDD
Mikrobac Tissues 2021-11-16-EU-Declaration of Conformity MDD
Mikrobac Virucidal Tissues 2021-11-16-EU-Declaration of Conformity MDD

BODE Prohlášení o shodě dle MDR

Bacillol 30 Sensitive_2021-06-29_EC-Declaration of Conformity MDR
Bomix plus_2021-06-29_EC-Declaration of Conformity MDR
Dismozon plus 2021-11-16-EC-Declaration of Conformity MDD
Korsolex basic_2021-08-25_EC-Declaration of Conformity MDR
Korsolex Endo-Cleaner_2021-07-08_EC-Declaration of Conformity MDR
Korsolex Endo-Disinfectant_2021-06-29_EC-Declaration of Conformity MDR
Korsolex PAA Test_2021-07-08_EC-Declaration of Conformity MDR
Korsolex PAA_2021-10-08_EC-Declaration of Conformity MDR
Single-use pump_2021-07-08_EC-Declaration of Conformity MDR

DANSAC Prohlášení o shodě

DOC-02146_1.0_Dansac MDR DOC Night Drainage Bag and Accessories
DOC-02164_2.0_Dansac MDR DOC Nova 2 - 2-Piece Ostomy Skin Barrier
DOC-02165_3.0_Dansac MDR DOC NovaLife 2 - Two-Piece Ostomy Skin Barrier
DOC-02209_2.0_Dansac MDR DOC NovaLife 1 - One-Piece Drainable Ostomy Pouch
DOC-02210_3.0_Dansac MDR DOC Nova 1 - One-Piece Drainable Ostomy Pouch
DOC-02246_2.0_Dansac MDR DOC NovaLife 1 - One-Piece Closed Ostomy Pouch
DOC-02247_1.0_Dansac MDR DOC Nova 1 - One-Piece Closed Ostomy Pouch
DOC-02251_3.0_Dansac MDR DOC NovaLife 2 - Two-Piece Closed Ostomy Pouch
DOC-02252_3.0_Dansac MDR DOC Nova 2 - Two-Piece Closed Ostomy Pouch
DOC-02257_2.0_Dansac MDR DOC Nova 1 - One-Piece Urostomy Pouch
DOC-02262_2.0_Dansac MDR DOC Nova 2 - Two-Piece Urostomy Pouch
DOC-02437_3.0_Dansac MDR DOC Nova 2 - Two-Piece Drainable Ostomy Pouch
DOC-02438_2.0_Dansac MDR DOC NovaLife 2 - Two-Piece Drainable Ostomy Pouch
DOC-02500_2.0_Dansac MDR DOC Skin Barrier Accessories
DOC-02525_2.0_Dansac MDR DOC Ostomy Pouch Accessories
DOC-02722_3.0_Dansac MDR DOC Irrigation Sets

OSTATNÍ Prohlášení o shodě dle IVD

PoS_HeptaPhan
PoS_PentaPhan

OSTATNÍ Prohlášení o shodě dle MDD

Aspen Surgical_CE C_komp CPT_08_2023
Aspen Surgical_PoS_komp CPT_2018
CE_declaration_of_conformity_final_překlad 2019
Declaration of conformity INCO 2016 EN+CZ
Depend_DoC_3_NL_Fitted_Briefs
Depend_DoC_9_NL_Pants_1
Depend_DoC_9_NL_Pants_HR
Gamagroup_bezp uzaver_EC C
Gamagroup_bezp uzaver_PoS
Gamaplus_CE C MED 170010_2022
Gamaplus_PoS_2022
INEX_Aestetic_kanyla irrigacni_EC C_12_2023
INEX_Aestetic_kanyla irrigacni_ISO 13485_2012_2019
INEX_CE Declaration of conformity_25072017
SENI_CLASSIC_ALL_2017
SENI_LADY_2019

OSTATNÍ Prohlášení o shodě dle MDR

1229 DependÂR SlipFitted Brief Normal - EN
1229 DependÂR SlipFitted Brief Super - EN
1235 Depend Pads Normal - EN
1237 Depend Pads Maximum - EN
EU Doc ABENA_Disposable Incontinence 2021 - INKONTINENCE
EU DoC Tena Lady Vlozky
EU DoC Tena Men Vlozky
EU DoC TENA Pants Unisex 2021-03
EU DoC TENA Slip 2021-02
Ontex ID_Declaration of Conformity 2021

VERBA Prohlášení o shodě dle MDR

EU-Declaration of Conformity Verba

VEROVAL

EC_Declaration_of_Conformity_MD_class_IIa-IIb-III_PHAG_2021_02_25
ECDoC_Veroval ACDC Adaptor_20170421
ECDoC_Veroval Compact BPU22_GCE606_20200402
ECDoC_Veroval DS 22 Infrared Thermometer_20200428
ECDoC_Veroval ECG and BPM_20190510
ECDoC_Veroval Upper Arm BPM_GCE604_20200402
ECDoC_Veroval wrist BPM_BPM25_20200301

VEROVAL IVD

DoC_Care diagnostica _2024
DoC_NanoRepro_Muzska plodnost_2024
DoC_NanoRepro_Nedostatek zeleza_2024
DoC_NanoRepro_Nesnasenlivost lepku_2024
DoC_NanoRepro_Prev zaludecnich onemoc_2024
EC Certifikat_Care diagnostica _2024
EC Certifikat_IVT Imuno_2021_cz
EC Certifikat_NanoRepro AG_2024
PoS_IVT Imuno_2021