Identity
- Trade Name
- EASY BREATH EUDAMEDBIOPSYBELL SRL FDA UDI
- Generic Name
- Heat/moisture exchanger, single-use FDA UDI
- Device Name
- EASY BREATH EUDAMEDTRACHEOSTOMY HUMIDIFIER (HME) FDA UDI
- Model / Reference
- BK008BN EUDAMEDEASY BREATH FDA UDI
- Description
- TRACHEOSTOMY HUMIDIFIER (HME) FDA UDI
Identifiers
- Catalog Number
- BK008BN FDA UDI
- Primary DI / UDI-DI
- 08033860016111 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033860016111 EUDAMED
- FDA Product Code
- BYD FDA UDI
- EMDN Code
- R040201 TRACHEOSTOMY HUMIDIFIERS EUDAMED
- GMDN Term
- Heat/moisture exchanger, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5375 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Heat/moisture exchanger, single-use
Biopsybell Srl by Biopsybell Srl — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biopsybell Srl
Sources (2)
- FDA UDI bd78d570-cca2-478a-9e3f-7eb57ccd9a10 35 fields · synced Jul 15, 2026
- EUDAMED eba444f0-bedb-4afd-b1de-091a111c4c81 61 fields · synced Jul 15, 2026