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Disposable Nasal Speculum
EUDAMEDFDA UDIClass I (EU MDR)
Ref 9877
by Bionix LLC
Identity
- Trade Name
- Disposable Nasal Speculum EUDAMEDBionix Development Corporation FDA UDI
- Generic Name
- Nasal speculum, single-use FDA UDI
- Device Name
- Disposable Nasal Speculum EUDAMEDDisposable Speculum-48 count FDA UDI
- Model / Reference
- 9877 EUDAMEDFDA UDI
- Description
- Disposable Speculum-48 count FDA UDI
Identifiers
- Catalog Number
- 9877 FDA UDI
- Primary DI / UDI-DI
- 00859911004191 EUDAMEDFDA UDI
- Basic UDI-DI
- 859911004SpeculumYH EUDAMED
- Unit of Use DI
- 10859911004198 EUDAMED
- FDA Product Code
- EPY FDA UDI
- EMDN Code
- Q030199 NASOPHARYNGEAL DEVICES - OTHER EUDAMED
- GMDN Term
- Nasal speculum, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.1800 FDA UDI
- Market of Registration
- Belgium 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Disposable Nasal Speculum by Bionix, LLC — 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 | 859911004SpeculumYH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bionix LLC
- EUDAMED SRN
- US-MF-000020408
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED c8b4ff52-4f6f-41f7-b800-4dcb9d16d109 61 fields · synced Jul 27, 2026
- FDA UDI da703d68-76ff-412f-a315-bd7447ec624a 35 fields · synced May 30, 2026