Identity
- Trade Name
- Trulife FDA UDI
- Generic Name
- Knee support orthosis FDA UDI
- Device Name
- Knee Cage EUDAMEDHINGED SWEDISH KNEE CAGE SM FDA UDI
- Model / Reference
- 0266802 EUDAMEDA24700 FDA UDI
- Description
- HINGED SWEDISH KNEE CAGE SM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00645517335674 EUDAMEDFDA UDI
- Basic UDI-DI
- 00645517KneeOrth4Q EUDAMED
- FDA Product Code
- ITQ FDA UDI
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
- GMDN Term
- Knee support orthosis FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3475 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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Knee support orthosis
Trulife by Trulife Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Knee support orthosis.
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- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
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
- Trulife Limited
Sources (2)
- FDA UDI 9f371714-6787-4e87-9211-6153c2132934 33 fields · synced Jun 19, 2026
- EUDAMED c579f485-af73-42af-9bc1-687bd4443f19 61 fields · synced Jun 19, 2026