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Neotech ChinStrap™ - Respiratory Support Accessory - X-Large
EUDAMEDFDA UDIClass I (EU MDR)
Ref N788Model ChinStrap™
Identity
- Trade Name
- Neotech ChinStrap™ - Respiratory Support Accessory - X-Large EUDAMEDNeotech ChinStrap™ FDA UDI
- Generic Name
- Pressure bandage, non-latex, single-use FDA UDI
- Device Name
- ChinStrap™ EUDAMEDThe Neotech ChinStrap is intended to help keep a patient’s mouth closed during respiratory therapy. It is intended for use on pediatric (neonates, infants and children) patients. FDA UDI
- Model / Reference
- ChinStrap™ EUDAMEDN788 EUDAMEDExtra Large FDA UDI
- Description
- The Neotech ChinStrap is intended to help keep a patient’s mouth closed during respiratory therapy. It is intended for use on pediatric (neonates, infants and children) patients. FDA UDI
Identifiers
- Catalog Number
- N788 FDA UDI
- Primary DI / UDI-DI
- 10812594012843 EUDAMEDFDA UDI
- Basic UDI-DI
- 081259401N78400P3 EUDAMED
- FDA Product Code
- CCX FDA UDI
- EMDN Code
- M0304010101 ELASTIC COMPRESSION BANDAGES, NON-ADHESIVE, LOW EXTENSIBILITY (<70%) EUDAMED
- GMDN Term
- Pressure bandage, non-latex, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.6820 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Neotech ChinStrap™ - Respiratory Support Accessory - X-Large by Neotech Products LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 081259401N78400P3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Neotech Products LLC
- EUDAMED SRN
- US-MF-000001895
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 5b883ed6-3a02-4254-abfe-3c42a55bece8 61 fields · synced Jun 18, 2026
- FDA UDI b978c2a2-65c5-4b38-89a1-18782317591a 34 fields · synced May 30, 2026