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Series Oro-Nasal Mask
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 113546Model 6500; 6600; 6700 - Series Oro-Nasal MaskModel 6500; 6600; 6700 Series
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 EUDAMED67 V2 ASSY MEDIUM 22OD W/HG FDA UDI
- Model / Reference
- 6500; 6600; 6700 - Series Oro-Nasal Mask EUDAMED113546 EUDAMED6500; 6600; 6700 Series EUDAMED6700 FDA UDI
- Description
- 67 V2 ASSY MEDIUM 22OD W/HG FDA UDI
Identifiers
- Catalog Number
- 113546 FDA UDI
- Primary DI / UDI-DI
- 00874750004553 EUDAMEDFDA UDI
- Basic UDI-DI
- 081713602691293C2 EUDAMED
- FDA Product Code
- BZD FDA UDI
- EMDN Code
- R0301010202 NIV MASKS 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
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
Series 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 | 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 afb2061a-ba18-4aab-ae32-c2345d11926a 61 fields · synced Jun 18, 2026
- FDA UDI 9f4da7c1-c9ee-4c45-b6d3-86734c5f420f 34 fields · synced May 29, 2026
- EUDAMED 924f95a8-f2a7-49a4-a5ff-8e968f8b90d9 61 fields · synced Jun 18, 2026