Identity
- Trade Name
- Tubifast Garment EUDAMEDTubifast® FDA UDI
- Generic Name
- Tubular support bandage, non-latex, reusable FDA UDI
- Device Name
- Tubifast EUDAMEDTubifast Leggings 11 - 14 yrs x 6 FDA UDI
- Model / Reference
- 992016 EUDAMEDFDA UDI
- Description
- Tubifast Leggings 11 - 14 yrs x 6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055158000742 EUDAMEDFDA UDI
- Basic UDI-DI
- 733243000000000064K2 EUDAMED
- FDA Product Code
- FQM FDA UDI
- EMDN Code
- M0303010103 ELASTIC FIXING BANDAGES, NON-ADHESIVE, EXTENSIBLE IN TWO DIRECTIONS EUDAMED
- GMDN Term
- Tubular support bandage, non-latex, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5075 FDA UDI
- Market of Registration
- Sweden 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
Category: Tubular support bandage, non-latex, reusable
Tubifast® by Mölnlycke Health Care AB — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mölnlycke Health Care AB
Sources (2)
- FDA UDI 5a89ae8f-8231-4140-9bd5-7be9dda9cf50 35 fields · synced Oct 6, 2026
- EUDAMED 69339cf7-22b0-4fc9-8908-1936542edbe8 61 fields · synced Sep 17, 2026