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TC-2 Hose Clip, 22F w/5 clips
EUDAMEDFDA UDIClass I (EU MDR)
Ref AB0009Model (T) Hose clip
Identity
- Trade Name
- TC-2 Hose Clip, 22F w/5 clips EUDAMEDGaleMed FDA UDI
- Generic Name
- Universal patient tubing holder, non-sterile FDA UDI
- Device Name
- Hose clip EUDAMEDDisposable Tube Clip 22mm FDA UDI
- Model / Reference
- (T) Hose clip EUDAMEDAB0009 EUDAMED70062 FDA UDI
- Description
- Disposable Tube Clip 22mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04710810082030 EUDAMEDFDA UDI
- Basic UDI-DI
- 471081008NNTB9L EUDAMED
- FDA Product Code
- JAY FDA UDI
- EMDN Code
- R028002 RESPIRATORY CIRCUITS SUPPORTS EUDAMED
- GMDN Term
- Universal patient tubing holder, non-sterile FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5280 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
TC-2 Hose Clip, 22F w/5 clips by GaleMed Corporation — 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 | 471081008NNTB9L | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GaleMed Corporation
- EUDAMED SRN
- TW-MF-000022411
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 30f415b8-8060-4131-a1e6-8762a45b126f 61 fields · synced Jun 18, 2026
- FDA UDI 55c43297-83f1-4ec9-925b-05680fb465ce 34 fields · synced May 30, 2026