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CONDUIT UNLEASH ATP 36° Double Angle Instruments Case
EUDAMEDFDA UDIClass I (EU MDR)
Ref LEC00140C
Identity
- Trade Name
- CONDUIT UNLEASH ATP 36° Double Angle Instruments Case EUDAMEDCONDUIT UNLEASH 36° ATP Double Angle Instruments Case FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Instrument Trays EUDAMEDTray/case used to hold other medical devices FDA UDI
- Model / Reference
- LEC00140C EUDAMEDFDA UDI
- Description
- Tray/case used to hold other medical devices FDA UDI
Identifiers
- Catalog Number
- LEC00140C FDA UDI
- Primary DI / UDI-DI
- 09421028119931 EUDAMEDFDA UDI
- Basic UDI-DI
- 942102811GMN00352C EUDAMED
- Direct Marketing DI
- 09421028119931 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
CONDUIT UNLEASH ATP 36° Double Angle Instruments Case by Enztec Limited — 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 | 942102811GMN00352C | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Enztec Limited
- EUDAMED SRN
- NZ-MF-000002264
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 82d69dd4-1051-4907-b4c6-703b0ef0253d 61 fields · synced Jul 24, 2026
- FDA UDI 0ba17b07-8fa0-4cd6-b2d8-22ca2023e4f8 34 fields · synced May 30, 2026