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EZCare™ Softouch - Tracheostomy Tube Holder - 5 Inch - Pink
EUDAMEDFDA UDIClass I (EU MDR)
Ref N9105PKModel EZCare™ Softouch
Identity
- Trade Name
- EZCare™ Softouch - Tracheostomy Tube Holder - 5 Inch - Pink EUDAMEDEZCare™ Softouch FDA UDI
- Generic Name
- Tracheostomy tube neck holder, single-use FDA UDI
- Device Name
- EZCare™ Softouch EUDAMEDThe EZCare Softouch is intended to secure a patient’s tracheostomy tube. It is intended for use on pediatric (neonates, infants and children) patients. FDA UDI
- Model / Reference
- EZCare™ Softouch EUDAMEDN9105PK EUDAMED5" Pink FDA UDI
- Description
- The EZCare Softouch is intended to secure a patient’s tracheostomy tube. It is intended for use on pediatric (neonates, infants and children) patients. FDA UDI
Identifiers
- Catalog Number
- N9105PK FDA UDI
- Primary DI / UDI-DI
- 10812594012188 EUDAMEDFDA UDI
- Basic UDI-DI
- 081259401N91050N3 EUDAMED
- FDA Product Code
- CBH FDA UDI
- EMDN Code
- V028099 NEONATOLOGY AND PEDIATRICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Tracheostomy tube neck holder, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5770 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
EZCare™ Softouch - Tracheostomy Tube Holder - 5 Inch - Pink 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 | 081259401N91050N3 | 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 d3c30779-3819-4c87-b187-0fb242e2d72f 61 fields · synced Jul 11, 2026
- FDA UDI 7fd47fe8-ce59-4088-9108-f7028f500023 34 fields · synced May 30, 2026