Series Oro-Nasal Mask
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- N/A FDA UDI
- Generic Name
- CPAP/BPAP face mask, single-use FDA UDI
- Device Name
- Series Oro-Nasal Mask EUDAMEDOro-Nasal Mask EUDAMEDHEADGEAR SMALL V2MASK SPU FDA UDI
- Model / Reference
- 6500; 6600; 6700 - Series Oro-Nasal Mask EUDAMED201547 EUDAMED6500; 6600; 6700 Series EUDAMED6600 FDA UDI
- Description
- HEADGEAR SMALL V2MASK SPU FDA UDI
Identifiers
- Catalog Number
- 201547 FDA UDI
- Primary DI / UDI-DI
- 00874750002498 EUDAMEDFDA UDI
- Basic UDI-DI
- 081713602691293C2 EUDAMED
- FDA Product Code
- BZD FDA UDI
- EMDN Code
- R9080 RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMEDR0301010201 CPAP MASKS EUDAMED
- GMDN Term
- CPAP/BPAP face mask, single-use 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Gas-sampling/monitoring respiratory tubing, single-use
Series 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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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081713602691293C2 | 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 c86e8e07-6fbb-49fa-a562-634171e9763a 61 fields · synced Jun 18, 2026
- FDA UDI 80dba60e-5a2c-4445-b5ac-907e94e43efd 34 fields · synced May 30, 2026
- EUDAMED 95896b89-7b61-4d20-b8fe-4bc8a725451c 61 fields · synced Jun 18, 2026