Authorized Representative
๐ง๐ฌ Bulgaria
Active
Compliance Management Solutions Europe LTD
SRN: BG-AR-000020809
ยท
2 Bulgaria Str., 2850 Petrich, Bulgaria
Manufacturers
12
Devices
66
Certificates
3
PRRCs
1
Basic Information
- Address
- 2 Bulgaria Str., 2850 Petrich, Bulgaria
- [email protected]
- VAT Number
- BG204899657
- Trade Register
- 204899657
- EORI
- We do not deal with products or customs so we do not have EORI number
Non-EU Manufacturers
| Name | Country | SRN |
|---|---|---|
| Control Bionics Inc. | ๐บ๐ธ United States | US-MF-000043550 |
| Eyerising International Pty Ltd | ๐ฆ๐บ Australia | AU-MF-000029570 |
| Prymax Healthcare LLP | ๐ฎ๐ณ India | IN-MF-000032225 |
| Sprig Oral Health Technologies, Inc | ๐บ๐ธ United States | US-MF-000029685 |
| Ozdent Pty Ltd | ๐ฆ๐บ Australia | AU-MF-000032618 |
| SureflO2 Trading Pty Ltd | ๐ฆ๐บ Australia | AU-MF-000045991 |
| Urgo Healthcare Products Co.,Ltd | ๐น๐ญ Thailand | TH-MF-000029677 |
| ICSION Medical Pty Ltd | ๐ฆ๐บ Australia | AU-MF-000030208 |
| Haemokinesis Ltd | ๐ฆ๐บ Australia | AU-MF-000033867 |
| Anatomics Pty Ltd | ๐ฆ๐บ Australia | AU-MF-000039116 |
| Open Airway Dental Solutions Australia Pty Ltd | ๐ฆ๐บ Australia | AU-MF-000041165 |
| iotaMotion, Inc. | ๐บ๐ธ United States | US-MF-000046509 |
Manufacturers
ICSION Medical Pty Ltd
Manufacturer
๐ฆ๐บ Australia·1 Basic UDI-DI·10 Devices·1 Importer
Eyerising International Pty Ltd
Manufacturer
๐ฆ๐บ Australia·1 Basic UDI-DI·1 Device·1 Importer
Open Airway Dental Solutions Australia Pty Ltd
Manufacturer
๐ฆ๐บ Australia
iotaMotion, Inc.
Manufacturer
๐บ๐ธ United States
Haemokinesis Ltd
Manufacturer
๐ฆ๐บ Australia·27 Basic UDI-DIs·29 Devices
Prymax Healthcare LLP
Manufacturer
๐ฎ๐ณ India·2 Basic UDI-DIs·3 Devices·DQS Medizinprodukte GmbH
Control Bionics Inc.
Manufacturer
๐บ๐ธ United States·1 Basic UDI-DI·1 Device
Anatomics Pty Ltd
Manufacturer
๐ฆ๐บ Australia
SureflO2 Trading Pty Ltd
Manufacturer
๐ฆ๐บ Australia·1 Basic UDI-DI·1 Device·DQS Medizinprodukte GmbH
Ozdent Pty Ltd
Manufacturer
๐ฆ๐บ Australia·1 Basic UDI-DI·1 Device·TรV SรD Product Service GmbH
Urgo Healthcare Products Co.,Ltd
Manufacturer
๐น๐ญ Thailand·5 Basic UDI-DIs·20 Devices·1 Importer
Sprig Oral Health Technologies, Inc
Manufacturer
๐บ๐ธ United States
Certificates
| Type | Number | Manufacturer | Notified Body | Status |
|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 170759665 | Prymax Healthcare LLP | DQS Medizinprodukte GmbH | Expired |
| MDD Annex V | 543045 MR5 | SureflO2 Trading Pty Ltd | DQS Medizinprodukte GmbH | Expired |
| MDD Annex II (excluding section 4) | G1 096382 0009 | Ozdent Pty Ltd | TรV SรD Product Service GmbH | Expired |
Devices
HOLDING PIPETTE
Device
EU MDR
·
Eu Md Class 1
·ICSION Medical Pty Ltd·On the market
INJECTION PIPETTE
Device
EU MDR
·
Eu Md Class 1
·ICSION Medical Pty Ltd·On the market
INJECTION PIPETTE
Device
EU MDR
·
Eu Md Class 1
·ICSION Medical Pty Ltd·On the market
INJECTION PIPETTE
Device
EU MDR
·
Eu Md Class 1
·ICSION Medical Pty Ltd·On the market
BIOPSY PIPETTE
Device
EU MDR
·
Eu Md Class 1
·ICSION Medical Pty Ltd·On the market
BIOPSY PIPETTE
Device
EU MDR
·
Eu Md Class 1
·ICSION Medical Pty Ltd·On the market
INJECTION PIPETTE
Device
EU MDR
·
Eu Md Class 1
·ICSION Medical Pty Ltd·On the market·2 countries
BIOPSY PIPETTE
Device
EU MDR
·
Eu Md Class 1
·ICSION Medical Pty Ltd·On the market·2 countries
HOLDING PIPETTES
Device
EU MDR
·
Eu Md Class 1
·ICSION Medical Pty Ltd·On the market·3 countries
HOLDING PIPETTE
Device
EU MDR
·
Eu Md Class 1
·ICSION Medical Pty Ltd·On the market
OPHTHALMOLOGICAL TREATMENT UNITS
Device
EU MDR
·
Eu Md Class 2a
·Eyerising International Pty Ltd·On the market·4 countries
DAY Anti-s P3BER
Device
EU IVDD
·
Eu Ivd General
·Haemokinesis Ltd·On the market
DAY Anti-S MS-94
Device
EU IVDD
·
Eu Ivd General
·Haemokinesis Ltd·On the market
DAY Anti-P1 650
Device
EU IVDD
·
Eu Ivd General
·Haemokinesis Ltd·On the market
DAY Anti-N LN3
Device
EU IVDD
·
Eu Ivd General
·Haemokinesis Ltd·On the market
DAY Anti-M LM110/140
Device
EU IVDD
·
Eu Ivd General
·Haemokinesis Ltd·On the market
DAY Anti-Lub LU2
Device
EU IVDD
·
Eu Ivd General
·Haemokinesis Ltd·On the market
DAY Anti-Leb P3F234MD4
Device
EU IVDD
·
Eu Ivd General
·Haemokinesis Ltd·On the market
DAY Anti-Lea P3N20V3
Device
EU IVDD
·
Eu Ivd General
·Haemokinesis Ltd·On the market
DAY Anti-k P3A118OL67
Device
EU IVDD
·
Eu Ivd General
·Haemokinesis Ltd·On the market
DAY Anti-Cw MS-110
Device
EU IVDD
·
Eu Ivd General
·Haemokinesis Ltd·On the market
DAY Anti-H lectin
Device
EU IVDD
·
Eu Ivd General
·Haemokinesis Ltd·On the market
DAY Anti-A1 lectin
Device
EU IVDD
·
Eu Ivd General
·Haemokinesis Ltd·On the market
DAYdiscs
Device
EU IVDR
·
Eu Ivd Class A
·Haemokinesis Ltd·On the market
DAY Dilution Plates
Device
EU IVDR
·
Eu Ivd Class A
·Haemokinesis Ltd·On the market
DAY Pipetting Tips
Device
EU IVDR
·
Eu Ivd Class A
·Haemokinesis Ltd·On the market
STATUS1 SATELLITE
Device
EU IVDD
·
Eu Ivd General
·Haemokinesis Ltd·On the market
STARGEL10 SATELLITE READER
Device
EU IVDD
·
Eu Ivd General
·Haemokinesis Ltd·On the market
STARGEL10 INCUBATOR
Device
EU IVDR
·
Eu Ivd Class A
·Haemokinesis Ltd·On the market
STARGEL10 CENTRIFUGE
Device
EU IVDR
·
Eu Ivd Class A
·Haemokinesis Ltd·On the market
STATUS1 CENTRIFUGE
Device
EU IVDR
·
Eu Ivd Class A
·Haemokinesis Ltd·On the market
DAY NEUTRAL GEL
Device
EU IVDR
·
Eu Ivd Class A
·Haemokinesis Ltd·On the market
DAY Neutral Gel
Device
EU IVDR
·
Eu Ivd Class A
·Haemokinesis Ltd·On the market
STARGEL10 NEUTRAL
Device
EU IVDR
·
Eu Ivd Class A
·Haemokinesis Ltd·On the market
STARGEL10 NEUTRAL
Device
EU IVDR
·
Eu Ivd Class A
·Haemokinesis Ltd·On the market
DAY Bromelin Reagent
Device
EU IVDR
·
Eu Ivd Class A
·Haemokinesis Ltd·On the market
DAY LISS Diluent
Device
EU IVDR
·
Eu Ivd Class A
·Haemokinesis Ltd·On the market
STATUS1 Solution
Device
EU IVDR
·
Eu Ivd Class A
·Haemokinesis Ltd·On the market
STARGEL10 STAR SOLUTION
Device
EU IVDR
·
Eu Ivd Class A
·Haemokinesis Ltd·On the market
DAYmate S
Device
EU IVDD
·
Eu Ivd General
·Haemokinesis Ltd·On the market
PrymaX PM
Device
EU MDD
·
Eu Md Class 2a
·Prymax Healthcare LLP·On the market·1 country
DRAINAGE SYSTEMS WITH ADJUSTABLE SUCTION - OTHER
Device
EU MDR
·
Eu Md Class 2a
·Prymax Healthcare LLP·On the market·1 country
DRAINAGE SYSTEMS WITH ADJUSTABLE SUCTION - OTHER
Device
EU MDR
·
Eu Md Class 2a
·Prymax Healthcare LLP·On the market·1 country
NeuroNode
Device
EU MDR
·
Eu Md Class 1
·Control Bionics Inc.·On the market·2 countries
RESPIRATORY MASKS - OTHER
Device
EU MDD
·
Eu Md Class 2a
·SureflO2 Trading Pty Ltd·On the market·1 country
ODONTOLOGY DEVICES - OTHER
Device
EU MDD
·
Eu Md Class 2a
·Ozdent Pty Ltd·On the market·1 country
URGO UNIVERSEL
Device
EU MDR
·
Eu Md Class 1
·Urgo Healthcare Products Co.,Ltd·On the market
URGO DURABLE
Device
EU MDR
·
Eu Md Class 1
·Urgo Healthcare Products Co.,Ltd·Not intended for eu market
URGODURABLE
Device
EU MDR
·
Eu Md Class 1
·Urgo Healthcare Products Co.,Ltd·Not intended for eu market
URGODURABLE
Device
EU MDR
·
Eu Md Class 1
·Urgo Healthcare Products Co.,Ltd·Not intended for eu market
URGODURABLE
Device
EU MDR
·
Eu Md Class 1
·Urgo Healthcare Products Co.,Ltd·Not intended for eu market
URGOSYVAL
Device
EU MDR
·
Eu Md Class 1
·Urgo Healthcare Products Co.,Ltd·Not intended for eu market
URGOSYVAL (STRONG ADHESIVE TAPE)
Device
EU MDR
·
Eu Md Class 1
·Urgo Healthcare Products Co.,Ltd·Not intended for eu market
URGOSYVAL
Device
EU MDR
·
Eu Md Class 1
·Urgo Healthcare Products Co.,Ltd·Not intended for eu market
URGOSYVAL
Device
EU MDR
·
Eu Md Class 1
·Urgo Healthcare Products Co.,Ltd·Not intended for eu market
URGOSYVAL
Device
EU MDR
·
Eu Md Class 1
·Urgo Healthcare Products Co.,Ltd·Not intended for eu market
URGOSYVAL
Device
EU MDR
·
Eu Md Class 1
·Urgo Healthcare Products Co.,Ltd·Not intended for eu market
URGOSYVAL
Device
EU MDR
·
Eu Md Class 1
·Urgo Healthcare Products Co.,Ltd·Not intended for eu market
URGO EXTREME
Device
EU MDR
·
Eu Md Class 1
·Urgo Healthcare Products Co.,Ltd·On the market
URGO EXTREME
Device
EU MDR
·
Eu Md Class 1
·Urgo Healthcare Products Co.,Ltd·On the market
URGO EXTREME
Device
EU MDR
·
Eu Md Class 1
·Urgo Healthcare Products Co.,Ltd·On the market
URGO EXTREME
Device
EU MDR
·
Eu Md Class 1
·Urgo Healthcare Products Co.,Ltd·On the market
PANSEMENTS TISSU-RESISTANT
Device
EU MDR
·
Eu Md Class 1
·Urgo Healthcare Products Co.,Ltd·On the market
URGO EXTREME
Device
EU MDR
·
Eu Md Class 1
·Urgo Healthcare Products Co.,Ltd·On the market
URGO EXTREME
Device
EU MDR
·
Eu Md Class 1
·Urgo Healthcare Products Co.,Ltd·On the market
CARREFOUR STRAPPING
Device
EU MDR
·
Eu Md Class 1
·Urgo Healthcare Products Co.,Ltd·On the market