Identity
- Trade Name
- CINCH - Tube Securement Device EUDAMEDCINCH FDA UDI
- Generic Name
- Dressing-fixation skin adhesive tape, non-silicone FDA UDI
- Device Name
- CINCH - Tube Securement Device EUDAMEDAMT CINCH Tube Securement Device - Medium FDA UDI
- Model / Reference
- CINCH417M EUDAMEDFDA UDI
- Description
- AMT CINCH Tube Securement Device - Medium FDA UDI
Identifiers
- Catalog Number
- CINCH417M, CINCH417M-10, CINCH417M-50 FDA UDI
- Primary DI / UDI-DI
- 00842071130947 EUDAMEDFDA UDI
- Basic UDI-DI
- 08420711CINCHA8 EUDAMED
- FDA Product Code
- PYO FDA UDI
- EMDN Code
- A0399 TUBULAR DEVICES - OTHER EUDAMED
- GMDN Term
- Dressing-fixation skin adhesive tape, non-silicone FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5240 FDA UDI
- Market of Registration
- Ireland 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
CINCH - Tube Securement Device by Applied Medical Technology, Inc. — 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 | 08420711CINCHA8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Applied Medical Technology, Inc.
- EUDAMED SRN
- US-MF-000041414
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED cd55fa14-5aa7-482f-9088-df60e26c09b6 61 fields · synced Jun 18, 2026
- FDA UDI d2f6c195-64f6-4ac3-8fa0-30666de6c608 35 fields · synced May 30, 2026