Breathe Easy XL Internal Nasal Splint
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Breatje-Easy XL EUDAMEDBreath-Easy EUDAMEDBreathe Easy XL Internal Nasal Splint FDA UDIBreathe Easy Internal Nasal Splint FDA UDI
- Generic Name
- Intranasal splint, non-biodegradable FDA UDI
- Device Name
- Internal Nasal Splint EUDAMEDBreathe Easy XL Internal Nasal Splint, Silicone FDA UDIBreathe Easy Internal Nasal Splint, Silicone FDA UDI
- Model / Reference
- 20-10510 EUDAMEDFDA UDI20-10500 EUDAMEDFDA UDIInternal Nasal Splint EUDAMED
- Description
- Breathe Easy XL Internal Nasal Splint, Silicone FDA UDIBreathe Easy Internal Nasal Splint, Silicone FDA UDI
Identifiers
- Catalog Number
- 20-10510 FDA UDI20-10500 FDA UDI
- Primary DI / UDI-DI
- 00818501020812 EUDAMEDFDA UDI00818501020751 EUDAMEDFDA UDI
- Basic UDI-DI
- 081850102IntNasalSplintHX EUDAMED
- FDA Product Code
- LYA FDA UDI
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
- GMDN Term
- Intranasal splint, non-biodegradable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4780 FDA UDI
- Market of Registration
- Austria EUDAMEDTürkiye EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Intranasal splint, non-biodegradable
Breathe Easy XL Internal Nasal Splint by Invotec International, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Intranasal splint, non-biodegradable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Invotec International, Inc.
Sources (4)
- FDA UDI f633b21a-9279-401c-96df-746264cdf911 34 fields · synced Jul 20, 2026
- FDA UDI c3a56671-c04a-42e2-bc8a-4439fdf8c5dc 34 fields · synced May 30, 2026
- EUDAMED 77d52102-acd5-4481-881f-5112f43d8fa6 61 fields · synced Jul 15, 2026
- EUDAMED c8f04817-e2e3-48d5-85fb-2eb0fad66caf 61 fields · synced Jul 20, 2026