header MDR ready NEW

MDR Dokumenty – vyhlásenie o zhode
a certifikáty

MDR Dokumenty – vyhlásenie
o zhode a certifikáty

HARTMANN Vyhlásenie o zhode podľa MDR

Consolidated_EU_Declaration_of_Conformity_Class_I_PHAG_2021_03_01
Consolidated_EU_Declaration_of_Conformity_Class_IIa_IIb_III_PHAG_2021_03_01
Consolidated_EU_Declaration_of_Conformity_Class_Is_PHAG_2021_03_01



HARTMANN Vyhlásenie o zhode podľa 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

EC certifikat_G1_011858_0064_Rev.01_e
EC certifikat_G1_011858_0064_Rev.01_e_attachment
EC_certifikat_G2S_011858_0063_Rev.00_e
EC_certifikat_G2S_011858_0063_Rev.00_e_supplement
EC_certifikat_G7_011858_0068_Rev.00_e



BODE EC certifikát

MED_CERT_93_42_engl



BODE Vyhlásenie o zhode podľa MDD

Bacillol 30 Foam_2020-02-25
Bacillol 30 Tissues
Bacillol AF_2019-10-22
Bacillol Tissues_2019-10-22
Bode X-Wipes
Bode X-Wipes_all
Bomix plus_2019-10-22
Korsolex basic_2019-10-22
Korsolex PAA_2019-10-22
Mikrobac forte_2019-10-22
Mikrobac Tissues_180215



BODE Vyhlásenie o zhode podľa MDR




DANSAC Vyhlásenie o zhode podľa MDD

DoC Dansac Nova 1 (FR-EOE2395)_2021
DoC Dansac Nova 2 (FR-EOE2397)_2021
DoC Dansac NovaLife 1 Convex & NovaLife 2 Convex Wafer (FR-EOE3358)_2021
DoC Dansac NovaLife 1&2 Closed (FR-EOE2994)_2021
DoC Dansac NovaLife 1&2 Open (FR-EOE3121)_2021
DoC Dansac NovaLife Soft Convex (FR-EOE3871)_2021
DoC Dansac_X-tra_Strips (FR-EOE4255)_2020



DANSAC Vyhlásenie o zhode podľa MDR

DOC-02164_1.0_Dansac MDR DOC Nova 2 - 2-Piece Ostomy Skin Barrier
DOC-02165_1.0_Dansac MDR DOC NovaLife 2 - Two-Piece Ostomy Skin Barrier
DOC-02209_1.0_Dansac MDR DOC NovaLife 1 - One-Piece Drainable Ostomy Pouch
DOC-02210_2.0_Dansac MDR DOC Nova 1 - One-Piece Drainable Ostomy Pouch
DOC-02246_1.0_Dansac MDR DOC NovaLife 1 - One-Piece Closed Ostomy Pouch
DOC-02251_1.0_Dansac MDR DOC NovaLife 2 - Two-Piece Closed Ostomy Pouch
DOC-02252_1.0_Dansac MDR DOC Nova 2 - Two-Piece Closed Ostomy Pouch
DOC-02257_1.0_Dansac MDR DOC Nova 1 - One-Piece Urostomy Pouch
DOC-02262_1.0_Dansac MDR DOC Nova 2 - Two-Piece Urostomy Pouch
DOC-02437_1.0_Dansac MDR DOC Nova 2 - Two-Piece Drainable Ostomy Pouch
DOC-02438_1.0_Dansac MDR DOC NovaLife 2 - Two-Piece Drainable Ostomy Pouch



OSTATNÉ Vyhlásenie o zhode podľa 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



OSTATNÉ Vyhlásenie o zhode podľa 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 TENA Pants Unisex 2021-03
EU DoC TENA Slip 2021-02



VERBA Vyhlásenie o zhode podľa 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
EC Certifikat_Care diagnostica_2024
EC Certifikat_IVT Imuno_2021_cz
PoS_IVT Imuno_2021