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Breathing Reservoir Bag (Test Lung)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 800-21001-1NPModel 800-21001
Identity
- Trade Name
- VADI MEDICAL FDA UDI
- Generic Name
- Lung physical simulator FDA UDI
- Device Name
- Breathing Reservoir Bag (Test Lung) EUDAMEDFDA UDI
- Model / Reference
- 800-21001 EUDAMEDFDA UDI800-21001-1NP EUDAMED
- Description
- Breathing Reservoir Bag (Test Lung) FDA UDI
Identifiers
- Catalog Number
- 800-21001-1NP FDA UDI
- Primary DI / UDI-DI
- 04719894380872 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04719894380872 EUDAMED
- FDA Product Code
- BTC FDA UDI
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
- GMDN Term
- Lung physical simulator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5320 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Pulmonary function analysis system, adult
Breathing Reservoir Bag (Test Lung) by VADI Medical Technology Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04719894380872 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- VADI Medical Technology Co., Ltd.
- EUDAMED SRN
- TW-MF-000022930
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (2)
- EUDAMED b1aec36c-a694-4251-9991-9fe87030fa87 61 fields · synced Jun 19, 2026
- FDA UDI b2037d48-655b-4650-8b73-f803f3cd39e4 34 fields · synced May 30, 2026