Veselības inspekcija bieži saņem informāciju no Eiropas Savienības dalībvalstīm par viltotiem paziņoto struktūru EK sertifikātiem, tādēļ vēršam uzmanību uz saņemto informāciju un iesakām izplatītājus/importētājus iepazīties ar to.
| Ražotāja nosaukums | Paziņotā struktūra (Notify body) un tās identifikācijas numurs | Viltotā EK sertifikāta numurs | Viltotajā EK sertifikātā norādītās medicīniskās ierīces | Viltotais EK sertifikāts |
| Vision Biyotenoloji Ar-Ge lab Sist.san.Ve Tic. Ltd. STi (Turcija) |
POLISH CENTRE FOR TESTING AND CERTIFICATION (NB 1434) |
1434-IVDD-446/2021 | VISION SARS-COV-2 ANTIGEN RAPID TEST KIT | |
| Foshan Nanhai Hager Medical Machinery Co., Ltd. (Ķīna) |
TUV SUD Product Service GmbH (NB 0123) |
G2 058482 0010 Rev.00 | Integral Dental Units | Nav pieejams |
| SOLİD TIBBİ MALZEMELER TURİZM İNŞ. İTH. İHR. SAN ve TİC. LTD. ŞTİ. (Turcija) |
NATIONAL EVALUATION CENTER OF OUALITY & TECHNOLOGY IN HEALTH S.A. (NB 0653) |
301011471 | Bone Plates & Bone Screws, lntramedullary Nails, Fixators, Hip and Knee Joint Prosthesis | |
| Sharma Ortho System Pvt. Ltd., (Indija) |
3EC International a.s. (NB 2265) |
2017-MDD/QS-032 | Orthopaedic Implants & Spinal Implants (Sterile / Non-Sterile) (Brand name: SHARMA) | Nav pieejams |
| JIANGSU SINOWISE TECHNOLOGY CO. LTD., (Ķīna) |
TUV SUD Product Service GmbH (NB 0123) |
G1 104715 0002 Rev.01 | Infusion Pump, Syringe Pump, Infusion Warmer, Patient Warming Machine | |
| MyLab Discovery Solutions PVT LTD (Indija) |
POLISH CENTRE FOR TESTING AND CERTIFICATION (NB 1434) |
1434-IVDD-648-2021 | CoviSelf COVID-19 Antigen Lateral Flow Test Device OTC Home Test | |
| Global Stem Cells Group (ASV) |
UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. (NB 2292) |
M.2020.106.13280 | Sterile Tissue Separation and Homogenization Containars | |
| Vision Biyotenoloji Ar-Ge lab Sist.san. VeTic. Ltd. (Turcija) |
POLISH CENTRE FOR TESTING AND CERTIFICATION (NB 1434) |
1434-IVDD-446/2021 | Vision SARS-COV-2 ANTIGEN RAPID TEST KIT | |
| Divine Medicure Technology (Indija) |
DNV GL PRESAFE AS (NB 2460) |
245067-2019-CE-IND-NA-PS Rev. 0.0 | Sterile surgical groomets, like ventilation tubes, middle ear implants, rhinological products for ear and nose surgeries | |
| JSC “MediStars” (Krievija) |
3EC International a.s. (NB 2265) |
2019-MDD/QS-033 | MediStars Intragastric Balloon | |
| Jining Hangxing E-Commerce Co., Ltd. (Ķīna) |
3EC International a.s. (NB 2265) |
2020-MDD/QS-008 |
Hyaluronan Soft Tissue Filing Gel Trade Name: Manorui |
|
| Jining Hangxing E-Commerce Co., Ltd. (Ķīna) |
3EC International a.s. (NB 2265) |
2020-MDD/DE-025 |
Hyaluronan Soft Tissue Filing Gel Trade Name: Manorui Cross Linked/ Non Cross Linked Hyaluronic Acid |
|
| EQUIMEDICAL BV (Nīderlande) |
DNV GL PRESAFE AS (NB 2460) |
12492-2018-CE-IBE-NA-PS Rev 1.0 | EQUISPON Sterile Haemostatic Absorbable Gelatin Sponges | Nav pieejams |
| EQUIMEDICAL BV (Nīderlande) |
DNV GL PRESAFE AS (NB 2460) |
12493-2018-CE-IBE-NA-PS Rev 1.0 | Sterile Haemostatic Absorbable Gelatin Sponges | Nav pieejams |
| Livealth Biopharma Pvt. Ltd. (Indija) |
POLISH CENTRE FOR TESTING AND CERTIFICATION (NB 1434) |
EC/2305 | Opthaflex -Sodium Hyaluronate Eye Drops; Livtear - Sodium Carboxymethyl Cellulose Lubricant Eye Drops 0.5% W/V | |
| Nakanishi Inc., (Japāna) |
TUV Rheinland LGA Products GmbH (CE 0197) |
DD 60014943 0001 | Led Curing Lights | |
| Nakanishi Inc. (Japāna) |
TUV Rheinland LGA Products GmbH (CE 0197) |
DD 60016946 0001 | Air Prophy Unit | |
| Nakanishi Inc. (Japāna) |
TUV Rheinland LGA Products GmbH (CE 0197) |
HD 60039923 0001 | Air turbine handpiece | |
| Neelkanth Polymer Industries (Indija) |
Presafe Denmark A/S (NB 0543) |
DGM 930 | Oral Dispenser, Rubber Dropper Assembly, Glass Dropper Assembly, Measuring Cups, Measuring Spoons, Pilfer Proof Caps, Child Resistance Caps (CRC), Flip Top Caps, Tablet Bottles, Silicon Rubber Teats, Eye Drop Bottles, Dry Syrup Bottles, Crew Caps, Adopter, Plastic Plug, Piles Applicators, PCO Caps, Baby Droppers Set, Tablet Applicators, Gel Applicators | |
| Core Technology Co., Ltd. (Ķīna) |
3EC International a.s. (NB 2265) |
2022-IVD/QS-007 | One Step HIV 1+2 Test (Strip C10-11, Cassette C10-20); One Step HBsAg Test (Strip B11-11, Cassette B11-20); One Step HCV Test (Strip B20-11, Cassette B20-20) | |
Norādām, ka informācija par viltotiem paziņoto struktūru EK sertifikātiem regulāri tiek atjaunota, tādēļ izplatītājiem/importētājiem iesakām ņemt vērā šo informāciju un jautājumu gadījumā iesakām vērsties pie Veselības inspekcijas Medicīnisko ierīču uzraudzības nodaļas zvanot pa tālruni – 67081611 vai rakstot uz e-pastu – vi@vi.gov.lv.