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Accessory with skin contact, single patient use
EUDAMEDFDA UDIClass I (EU MDR)
Ref 892121
Identity
- Trade Name
- Vyaire FDA UDI
- Generic Name
- Nose clip, single-use FDA UDI
- Device Name
- Accessory with skin contact, single patient use EUDAMEDNose clip pad FDA UDI
- Model / Reference
- 892121 EUDAMEDFDA UDI
- Description
- Nose clip pad FDA UDI
Identifiers
- Catalog Number
- 892121 FDA UDI
- Primary DI / UDI-DI
- 14250892903023 EUDAMEDFDA UDI
- Basic UDI-DI
- 42508929011811PX EUDAMED
- FDA Product Code
- BXJ FDA UDI
- EMDN Code
- Z12159085 VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Nose clip, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.6225 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Accessory with skin contact, single patient use by Jaeger Medical GmbH — Class I — 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 | 42508929011811PX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Jaeger Medical GmbH
- EUDAMED SRN
- DE-MF-000007090
Sources (2)
- EUDAMED caffd583-2e1c-40e7-90fd-e71e33657634 61 fields · synced Jun 18, 2026
- FDA UDI f19879c9-1442-44ea-af4a-2aee870a77c0 36 fields · synced May 25, 2026