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Oro-Nasal Mask
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 113579Model 7600; 7700 Series
Identity
- Trade Name
- N/A FDA UDI
- Generic Name
- CPAP/BPAP face mask, reusable FDA UDI
- Device Name
- Oro-Nasal Mask EUDAMED76 V2 ASSY PETITE 22ID NO HG FDA UDI
- Model / Reference
- 7600; 7700 Series EUDAMED113579 EUDAMED7600 FDA UDI
- Description
- 76 V2 ASSY PETITE 22ID NO HG FDA UDI
Identifiers
- Catalog Number
- 113579 FDA UDI
- Primary DI / UDI-DI
- 00874750003648 EUDAMEDFDA UDI
- Basic UDI-DI
- 081713602691236BN EUDAMED
- Direct Marketing DI
- 00874750003648 EUDAMED
- 510(k) Number
- K030822 FDA UDI
- FDA Product Code
- BZD FDA UDI
- EMDN Code
- R0301010201 CPAP MASKS EUDAMED
- GMDN Term
- CPAP/BPAP face mask, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5905 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
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 | 081713602691236BN | 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 505564fc-3b3b-4c15-87c0-62aa15eb01d7 61 fields · synced Jun 18, 2026
- FDA UDI f4b10d33-8fea-4947-aa13-e90af898c1ea 35 fields · synced May 25, 2026