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oro-nasal mask
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 113471Model Series oro-nasal masks 7500Model 7500 Series
Identity
- Trade Name
- N/A FDA UDI
- Generic Name
- CPAP/BPAP face mask, reusable FDA UDI
- Device Name
- oro-nasal mask EUDAMED7500L NIV 22ID ELB STDHDGR SS FDA UDI
- Model / Reference
- Series oro-nasal masks 7500 EUDAMED113471 EUDAMED7500 Series EUDAMED7500 FDA UDI
- Description
- 7500L NIV 22ID ELB STDHDGR SS FDA UDI
Identifiers
- Catalog Number
- 113471 FDA UDI
- Primary DI / UDI-DI
- 00874750002733 EUDAMEDFDA UDI
- Basic UDI-DI
- 081713602691241BF EUDAMED
- Direct Marketing DI
- 00874750002733 EUDAMED
- 510(k) Number
- K030515 FDA UDI
- FDA Product Code
- CBK FDA UDI
- EMDN Code
- R0301010202 NIV MASKS EUDAMED
- GMDN Term
- CPAP/BPAP face mask, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 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
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
Category: Rebreathing oxygen face mask
oro-nasal mask by Hans Rudolph, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Rebreathing oxygen face mask.
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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 | 081713602691241BF | 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 (3)
- EUDAMED 96b15f42-b0cd-4c5b-bb00-6e55fd38b040 61 fields · synced Jun 18, 2026
- FDA UDI ea9d2591-a55a-4364-b1f5-0496f06673bd 35 fields · synced May 30, 2026
- EUDAMED 24e9f18d-a2c2-4ffa-8bc6-7aeec9e05957 61 fields · synced Jun 18, 2026