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Oro-Nasal Mask
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 115011Model 7301; 7302 Series
Identity
- Trade Name
- 7301 EAGLE1 FDA UDI
- Generic Name
- Rebreathing oxygen face mask FDA UDI
- Device Name
- Oro-Nasal Mask EUDAMEDE1 MASK & HG MEDIUM TFX LABEL FDA UDI
- Model / Reference
- 7301; 7302 Series EUDAMED115011 EUDAMED7301 FDA UDI
- Description
- E1 MASK & HG MEDIUM TFX LABEL FDA UDI
Identifiers
- Catalog Number
- 115011 FDA UDI
- Primary DI / UDI-DI
- 00817136024615 EUDAMEDFDA UDI
- Basic UDI-DI
- 081713602691312BD EUDAMED
- FDA Product Code
- BYG FDA UDI
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
- GMDN Term
- Rebreathing oxygen face mask FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5580 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Oro-Nasal Mask by Hans Rudolph, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081713602691312BD | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Hans Rudolph Inc
- EUDAMED SRN
- US-MF-000004498
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (2)
- EUDAMED 5280f3f1-d7c8-4ed3-95bd-36954bea98fb 61 fields · synced Jun 18, 2026
- FDA UDI 95a0688d-a159-4ee7-a2fa-aabf2590442c 34 fields · synced May 30, 2026