Authorized Representative
๐ฎ๐ช Ireland
Active
Elara Pharmaservices Europe Ltd
SRN: IE-AR-000011852
ยท
Regus Block 1 Office 107, D15 AKK1 Dublin 15, Ireland
Manufacturers
8
Devices
53
Certificates
4
PRRCs
1
Basic Information
- Address
- Regus Block 1 Office 107, D15 AKK1 Dublin 15, Ireland
- [email protected]
- Phone
- +353 1 960 1692
- VAT Number
- IE03568692IH
- Trade Register
- 634834
- EORI
- IE3568692IH
Non-EU Manufacturers
| Name | Country | SRN |
|---|---|---|
| Meditech Endoscopy Limited | ๐ฌ๐ง United Kingdom | GB-MF-000014143 |
| Compression Works, Inc | ๐บ๐ธ United States | US-MF-000021119 |
| Ennogen Healthcare International Limited | ๐ฌ๐ง United Kingdom | UK-MF-000039877 |
| Medtech Products Inc | ๐บ๐ธ United States | US-MF-000034441 |
| Vitame Ltd | ๐ฌ๐ง United Kingdom | GB-MF-000015647 |
| Ennogen Healthcare Ltd | ๐ฌ๐ง United Kingdom | GB-MF-000022280 |
| Garmentec Group Ltd | ๐ฌ๐ง United Kingdom | GB-MF-000015646 |
| DenTek Oral Care Limited | ๐ฌ๐ง United Kingdom | GB-MF-000034440 |
Manufacturers
Medtech Products Inc
Manufacturer
๐บ๐ธ United States·1 Basic UDI-DI·1 Device·Eurofins Product Testing Italy S.r.l. and Eurofins Product Testing Italy S.r.l.
Vitame Ltd
Manufacturer
4 Basic UDI-DIs·7 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.
Garmentec Group Ltd
Manufacturer
1 Basic UDI-DI·1 Device
Meditech Endoscopy Limited
Manufacturer
2 Basic UDI-DIs·3 Devices·2 Importers
DenTek Oral Care Limited
Manufacturer
2 Basic UDI-DIs·11 Devices·1 Importer
Ennogen Healthcare International Limited
Manufacturer
3 Basic UDI-DIs·16 Devices
Compression Works, Inc
Manufacturer
๐บ๐ธ United States·1 Basic UDI-DI·1 Device·2 Importers
Ennogen Healthcare Ltd
Manufacturer
2 Basic UDI-DIs·13 Devices
Certificates
| Type | Number | Manufacturer | Notified Body | Status |
|---|---|---|---|---|
| MDD Annex II (excluding section 4) | EPT 0477.MDD.19/3485 | Medtech Products Inc | Eurofins Product Testing Italy S.r.l. | Expired |
| MDD Annex II Section 4 | EPT 0477.MDD.19/3484 | Medtech Products Inc | Eurofins Product Testing Italy S.r.l. | Expired |
| MDD Annex V | 623697 | Vitame Ltd | BSI Group The Netherlands B.V. | Expired |
| MDD Annex V | CE 623697 | Vitame Ltd | BSI Group The Netherlands B.V. | Expired |
Devices
Murine Bright and Moist
Device
EU MDD
·
Eu Md Class 3
·Medtech Products Inc·On the market·4 countries
Dermogesic non-flammable Cold Spray
Device
EU MDD
·
Eu Md Class 2a
·Vitame Ltd·On the market·2 countries
Cryogesic Direct Stream
Device
EU MDD
·
Eu Md Class 2a
·Vitame Ltd·On the market·2 countries
Cyrogesic Fine Spray
Device
EU MDD
·
Eu Md Class 2a
·Vitame Ltd·On the market·2 countries
Dermogesic Non-Flammable Cold Spray (Fine Spray)
Device
EU MDR
·
Eu Md Class 2a
·Vitame Ltd·On the market·1 country
Dermogesic Non-flammable Cold Spray (Direct Stream)
Device
EU MDR
·
Eu Md Class 2a
·Vitame Ltd·On the market·1 country
Cryogesic Direct Stream
Device
EU MDR
·
Eu Md Class 2a
·Vitame Ltd·On the market·1 country
Cryogesic Fine Spray
Device
EU MDR
·
Eu Md Class 2a
·Vitame Ltd·On the market·2 countries
Poc-KIT Stretcher
Device
EU MDR
·
Eu Md Class 1
·Garmentec Group Ltd·On the market·3 countries
STERILISATION CONTAINERS - OTHER
Device
EU MDR
·
Eu Md Class 1
·Meditech Endoscopy Limited·On the market
CLEANING AND DISINFECTION EQUIPMENT
Device
EU MDR
·
Eu Md Class 1
·Meditech Endoscopy Limited·On the market
StageOne N
Device
EU MDR
·
Eu Md Class 1
·Meditech Endoscopy Limited·On the market
EKULF Tooth Repair Kit
Device
EU MDR
·
Eu Md Class 1
·DenTek Oral Care Limited·On the market·3 countries
Dental First Aid Kit
Device
EU MDR
·
Eu Md Class 1
·DenTek Oral Care Limited·On the market·2 countries
Temparin Max Repair Kit 12+ (2.64g)
Device
EU MDR
·
Eu Md Class 1
·DenTek Oral Care Limited·On the market·4 countries
Essentials Temporary Repair Kit 5+ (1.1g)
Device
EU MDR
·
Eu Md Class 1
·DenTek Oral Care Limited·On the market
Temparin Max Repair Kit 24+ (2 x 2.64g)
Device
EU MDR
·
Eu Md Class 1
·DenTek Oral Care Limited·On the market·2 countries
Temparin Max Repair Kit 5+ (1.1g)
Device
EU MDR
·
Eu Md Class 1
·DenTek Oral Care Limited·On the market
Shiepzโข Anti Tandenknars
Device
EU MDR
·
Eu Md Class 1
·DenTek Oral Care Limited·On the market
EKULF NightGuard
Device
EU MDR
·
Eu Md Class 1
·DenTek Oral Care Limited·On the market
Maximum Protection Dental Guard
Device
EU MDR
·
Eu Md Class 1
·DenTek Oral Care Limited·On the market·3 countries
Comfort-Fit Dental Guard
Device
EU MDR
·
Eu Md Class 1
·DenTek Oral Care Limited·On the market·2 countries
Maximum Protection Dental Guard
Device
EU MDR
·
Eu Md Class 1
·DenTek Oral Care Limited·On the market·4 countries
Enopen
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare International Limited·On the market
Enopen
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare International Limited·On the market
Enopen
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare International Limited·On the market
Enopen
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare International Limited·On the market
Fifty:50
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare International Limited·On the market
Fifty:50
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare International Limited·On the market
Thirty:30
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare International Limited·On the market
Thirty30
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare International Limited·On the market
Aquasoothe 2%
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare International Limited·On the market
Aquasoothe 1%
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare International Limited·On the market
Aquasoothe 1%
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare International Limited·On the market
Silconex Scar Treatment Gel
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare International Limited·On the market
Silconex Scar Treatment Gel
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare International Limited·On the market
Silconex Scar Treatment Gel
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare International Limited·On the market
Silconex Scar Treatment Gel
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare International Limited·On the market
Derma Protective Plus Skin Protectant
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare International Limited·On the market
HAEMOSTASIS MECHANICAL SYSTEMS (INCLUDING SINGLE-USE TOURNIQUETS)
Device
EU MDR
·
Eu Md Class 1
·Compression Works, Inc·On the market·29 countries
Derma Protective Plus
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare Ltd·On the market
Emulsifying Ointment
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare Ltd·On the market
Aquasoothe 2% 500g
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare Ltd·On the market
Aquasoothe 1% 500g
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare Ltd·On the market
Aquasoothe 1% 100g
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare Ltd·On the market
Fifty:50 Ointment 500g
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare Ltd·On the market
Fifty:50 Ointment 250g
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare Ltd·On the market
Enopen 1050g
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare Ltd·On the market
Enopen 500g
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare Ltd·On the market
Enopen 150g
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare Ltd·On the market
Enopen 50g
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare Ltd·On the market
Thirty:30 500g
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare Ltd·On the market
Thirty:30 125g
Device
EU MDR
·
Eu Md Class 1
·Ennogen Healthcare Ltd·On the market