Identity
- Trade Name
- "Fortune" FixPad Anchoring Device (Non-Sterile) EUDAMEDFixPad Anchoring Device FDA UDI
- Generic Name
- Wearable percutaneous catheter/tube holder FDA UDI
- Device Name
- "Fortune" FixPad Anchoring Device (Non-Sterile) EUDAMED
- Model / Reference
- 1800-0005 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 14711182607989 EUDAMEDFDA UDI
- Basic UDI-DI
- B-14711182607989 EUDAMED
- FDA Product Code
- MZR FDA UDI
- EMDN Code
- V80 CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Wearable percutaneous catheter/tube holder FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5240 FDA UDI
- Market of Registration
- Belgium 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Category: Wearable percutaneous catheter/tube holder
FixPad Anchoring Device by Fortune Medical Instrument Corp. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Wearable percutaneous catheter/tube holder.
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- Grip-Lok — TIDI PRODUCTS, LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
Sources (2)
- FDA UDI 73f4b13d-a863-4ca3-9649-c4e79fe8312b 32 fields · synced Jul 26, 2026
- EUDAMED bd4eb5c3-87c2-4c91-b425-7ec485e20f89 61 fields · synced Jul 26, 2026