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Neonatal Test Lung, reusable
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref MP20050Model 1080536K19Z000
Identity
- Trade Name
- Neonatale Testlunge, Mehrweg EUDAMEDNeonatal Test Lung, reusable FDA UDI
- Generic Name
- Lung physical simulator FDA UDI
- Model / Reference
- MP20050 EUDAMEDFDA UDI1080536K19Z000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675643722 EUDAMEDFDA UDI
- Basic UDI-DI
- 0404867511080536K19Z000T5 EUDAMED
- Direct Marketing DI
- 04048675643722 EUDAMED
- FDA Product Code
- BTC FDA UDI
- EMDN Code
- Z1203010180 ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Lung physical simulator FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5320 FDA UDI
- Market of Registration
- Germany 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Lung physical simulator
Neonatal Test Lung, reusable by Drägerwerk AG & Co. KGaA — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA UDI 626eec46-5e18-42f0-a540-1f381636ac81 32 fields · synced Jul 19, 2026
- EUDAMED 2e594ec5-11bc-42d9-9f08-78fc759ccfbc 61 fields · synced Jul 19, 2026