Novae
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Instrument SERF EUDAMEDNOVAE FDA UDI
- Generic Name
- Acetabulum prosthesis trial, prefabricated, reusable FDA UDI
- Device Name
- Instrument plastic trial (cup) EUDAMED
- Model / Reference
- 3662200_3HTRLCPNSP001GN EUDAMEDRA90196128 EUDAMEDIR61/28 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03662200020409 EUDAMEDFDA UDI
- Basic UDI-DI
- 3662200_3HTRLCPNSP001GN EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Acetabulum prosthesis trial, prefabricated, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Acetabulum prosthesis trial, prefabricated, reusable
Novae by Soc Etudes Recherches Fabrication — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Acetabulum prosthesis trial, prefabricated, reusable.
- Trabecular Metal® — Zimmer, Inc. · Class I
- G7 PROVISIONAL SHELL — Biomet Orthopedics, Inc. · Class II
- Bipolar Head — Limacorporate · Class II
- Acetabular Cups — Limacorporate · Class II
- Novation — Exactech, Inc. · Class I
- TRIAL NECK for Exacta S Rasp - Mark S - Standard — Permedica S.p.A · Class IIa
- INSTRUMENT — Howmedica Osteonics Corp. · Class II
- MultiPolar® — Zimmer, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- Soc Etudes Recherches Fabrication
Sources (2)
- FDA UDI 0f6606c9-09f5-4452-92a0-917add7a24a1 32 fields · synced Oct 10, 2026
- EUDAMED 0568b7a4-a325-4944-96c0-efd57fd6da3d 61 fields · synced Oct 10, 2026