Authorized Representative
🇩🇪 Germany
Active
Chalice Medical Europe GmbH
SRN: DE-AR-000007891
·
Alter Landweg 11, 32584 Löhne, Germany
Manufacturers
1
Devices
96
Certificates
3
PRRCs
1
Basic Information
- Address
- Alter Landweg 11, 32584 Löhne, Germany
- [email protected]
- VAT Number
- DE330419139
- Trade Register
- HRB17116
- EORI
- DE917482060076264
Non-EU Manufacturers
| Name | Country | SRN |
|---|---|---|
| Chalice Medical Ltd | 🇬🇧 United Kingdom | GB-MF-000010617 |
Manufacturers
Certificates
| Type | Number | Manufacturer | Notified Body | Status |
|---|---|---|---|---|
| MDD Annex V | 687569 | Chalice Medical Ltd | BSI Group The Netherlands B.V. | Expired |
| MDD Annex V | CE 687569 | Chalice Medical Ltd | BSI Group The Netherlands B.V. | Expired |
| MDD Annex II Section 4 | CE 687568 | Chalice Medical Ltd | BSI Group The Netherlands B.V. | Expired |
Devices
Paragon Infant PP Oxygenator
Device
EU MDD
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
Paragon Adult PP Oxygenator
Device
EU MDD
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
Paragon Adult Midi Integrated Oxygenator with Micronet Filter
Device
EU MDD
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·3 countries
Paragon Adult Maxi Integrated Oxygenator with Micronet Filter
Device
EU MDD
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
Paragon Infant Integrated Oxygenator
Device
EU MDD
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
OXYGENATOR KITS
Device
EU MDD
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·2 countries
Paragon Adult Midi Integrated Oxygenator
Device
EU MDD
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
Paragon Infant Micronet Integrated Oxygenator
Device
EU MDD
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·2 countries
Paragon Adult Maxi Integrated Oxygenator
Device
EU MDD
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
1.2 Haemoconcentrator Set
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·No longer on the market·1 country
0.3 Haemoconcentrator Tubing Set
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·No longer on the market·1 country
0.7 Pre-Connected Haemo Set
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·No longer on the market·1 country
Haemofilter Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·3 countries
Neonatal ECMO Tubing Pack without Oxy
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
ParaTherm Heater / Cooler
Device
EU MDD
·
Eu Md Class 2b
·Chalice Medical Ltd·No longer on the market·3 countries
0.3 Haemoconcentrator Tubing Pack
Device
EU MDD
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
1.2 Haemoconcentrator Tubing Pack
Device
EU MDD
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
0.7 Haemoconcentrator Tubing Pack
Device
EU MDD
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
ECMO Tubing Pack with Infant Paragon PMP Oxygenator
Device
EU MDD
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
3 Metre Blue Water Line
Device
EU MDR
·
Eu Md Class 1
·Chalice Medical Ltd·On the market·1 country
1.5m Blue Water Lines
Device
EU MDR
·
Eu Md Class 1
·Chalice Medical Ltd·Not intended for eu market
1.5m Blue Water Lines with Straight Hansen Connectors
Device
EU MDR
·
Eu Md Class 1
·Chalice Medical Ltd·Not intended for eu market
3m Water Line with Elbow Hanson Connectors
Device
EU MDR
·
Eu Md Class 1
·Chalice Medical Ltd·On the market·2 countries
Blue 3m Water Lines with Hansen Connectors
Device
EU MDR
·
Eu Md Class 1
·Chalice Medical Ltd·Not intended for eu market
Blue 3m Water Lines with Elbow Hansen Connectors
Device
EU MDR
·
Eu Md Class 1
·Chalice Medical Ltd·Not intended for eu market
3/8" Male to Male Hansen Adapter
Device
EU MDR
·
Eu Md Class 1
·Chalice Medical Ltd·Not intended for eu market
3m Grey Water Lines with Elbow Hansen Connectors
Device
EU MDR
·
Eu Md Class 1
·Chalice Medical Ltd·Not intended for eu market
1.5 Grey Water Lines with Straight Hansen Connectors
Device
EU MDR
·
Eu Md Class 1
·Chalice Medical Ltd·Not intended for eu market
90o Hansen Connectors
Device
EU MDR
·
Eu Md Class 1
·Chalice Medical Ltd·Not intended for eu market
3 Metre grey water lines with straight hansen connectors for ParaTherm
Device
EU MDR
·
Eu Md Class 1
·Chalice Medical Ltd·Not intended for eu market
Straight Hansen Connectors
Device
EU MDR
·
Eu Md Class 1
·Chalice Medical Ltd·On the market·1 country
Adult ECMO Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
Neonatal ECMO Tubing Pack without Oxygenator
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
Adult ECMO Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·Not intended for eu market
Adult ECMO Tubing Pack without Oxygenator
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
1/4" Pedivas ECMO Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
Infant ECMO Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·Not intended for eu market
Neonatal ECMO Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·Not intended for eu market
20m Gas Line
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
Pressure Set
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·3 countries
Tubing Pack for DOE
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
Hemo Tubing Set
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·3 countries
Adult Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·3 countries
Loop 5 Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·3 countries
Loop 4 Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·3 countries
Loop 3 Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·2 countries
Loop 2 Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·2 countries
Loop 1 Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·2 countries
HTP 42 Basic Set
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·3 countries
Haemoperfusion Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·2 countries
Standard Infant ECC Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·Not intended for eu market
Spare Coiled Lines
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
Standard Adult EEC Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·Not intended for eu market
Tubing for ECC/BC 4:1
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
HLM Adult Set
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·Not intended for eu market
HLM Infant Set
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·Not intended for eu market
HLM Paediatric Set
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·Not intended for eu market
High Flow Pigtail
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
3/16 x 1/16 x 60cm Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
Neonatal Bridge Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
Spare Pump Boot
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
High Flow Pigtail
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
1/4 Y Connector
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
Adult VAD Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
Paediatric VAD Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·Not intended for eu market
Adult VAD Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
Pediatric VAD Tubing Pack (for use with PediVas)
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·31 countries
Adult VAD Tubing Pack (For use with CentriMag)
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·31 countries
Standard Infant ECC Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·Not intended for eu market
Standard Infant ECC Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·No longer on the market·1 country
Standard Adult ECC Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·Not intended for eu market
Standard Adult ECC Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·No longer on the market·1 country
Tubing Set Type A
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·Not intended for eu market
Tubing Set Type I
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·Not intended for eu market
1/4 x 3/8 Paediatric Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·Not intended for eu market
3/8 x 3/8 Adult Set
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·Not intended for eu market
1/4 x 3/16 Infant Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·Not intended for eu market
1/4 x 1/4 Paediatric Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·Not intended for eu market
1/2 x 3/8 Adult Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·Not intended for eu market
Haemo Tubing Set
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
Standard Adult Midi ECC Tubing Pack
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
VAVD Tubing Set
Device
EU MDR
·
Eu Md Class 2a
·Chalice Medical Ltd·Not intended for eu market
Holder for Standalone Paragon Neonatal Oxygenator
Device
EU MDR
·
Eu Md Class 1
·Chalice Medical Ltd·On the market·2 countries
Holder for Integrated Paragon Adult Oxygenator with 4000ml Reservoir
Device
EU MDR
·
Eu Md Class 1
·Chalice Medical Ltd·On the market·1 country
Holder for Integrated Paragon Oxygenator with 1800ml Reservoir
Device
EU MDR
·
Eu Md Class 1
·Chalice Medical Ltd·On the market·1 country
Holder for Integrated Paragon Oxygenator
Device
EU MDR
·
Eu Md Class 1
·Chalice Medical Ltd·On the market·2 countries
VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
Device
EU MDR
·
Eu Md Class 1
·Chalice Medical Ltd·On the market·10 countries
OXYGENATOR KITS
Device
EU MDD
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·2 countries
OXYGENATOR KITS
Device
EU MDD
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·6 countries
OXYGENATOR KITS
Device
EU MDD
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
OXYGENATOR KITS
Device
EU MDD
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·2 countries
OXYGENATOR KITS
Device
EU MDD
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
OXYGENATOR KITS
Device
EU MDD
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·1 country
OXYGENATOR KITS
Device
EU MDD
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·6 countries
OXYGENATOR KITS
Device
EU MDD
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·5 countries
DRAINAGE AND FLUID COLLECTION DEVICES - OTHER
Device
EU MDD
·
Eu Md Class 2a
·Chalice Medical Ltd·On the market·3 countries