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RespiChamber*
EUDAMEDClass I (EU MDR)
Ref 113557/113557110050Ref 113536/113536110050Ref 113501/113501110120Model 113501Ref 113537/113537110050
Identity
- Trade Name
- RespiChamber* EUDAMEDRespiChamber EUDAMED
- Device Name
- Valved Holding Chamber EUDAMEDRespiChamber* Static -Resistant Valved Holding Chamber For use with Metered Dose Inhalers EUDAMED
- Model / Reference
- 113557/113557110050 EUDAMED113536/113536110050 EUDAMED113501 EUDAMED113501/113501110120 EUDAMED113537/113537110050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00762860000452 EUDAMED00762860000438 EUDAMED00762860000414 EUDAMED00762860000445 EUDAMED
- Basic UDI-DI
- 762860VHC1NL EUDAMEDB-00762860000414 EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMEDGermany EUDAMEDTürkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulmonary function analysis system, adult
RespiChamber* by Trudell Medical International — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 762860VHC1NL | Class I | Active |
| EUDAMED | European Union | CE/MDR | 762860VHC1NL | Class I | Active |
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Manufacturer
- Manufacturer
- Trudell Medical International
- EUDAMED SRN
- CA-MF-000009860
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED 88f72560-fff8-447c-b979-3360622ccbcf 61 fields · synced Jul 14, 2026
- EUDAMED 0705bbd3-fa34-4903-9275-8745f812fa27 61 fields · synced May 17, 2026
- EUDAMED d30b2b56-6971-4852-9d8d-253643da4986 61 fields · synced May 17, 2026
- EUDAMED d790330d-56b6-40a2-9cda-29949a001ef6 61 fields · synced May 17, 2026