HYPE stem
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Instrument SERF EUDAMEDHYPE stem FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Instrument plastic trial (stem) EUDAMED
- Model / Reference
- 3662200_3HTRLSTNSP001UA EUDAMEDRA90240228 EUDAMEDCOEH 10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03662200017935 EUDAMEDFDA UDI
- Basic UDI-DI
- 3662200_3HTRLSTNSP001UA EUDAMED
- FDA Product Code
- HWT FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
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: Orthopaedic prosthesis implantation positioning instrument, reusable
HYPE stem by Soc Etudes Recherches Fabrication — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 62dad116-4643-4530-b3a5-dbb8b4ef11d4 32 fields · synced Oct 10, 2026
- EUDAMED 418370d3-d68e-4b00-8aa0-3cca8daf032e 61 fields · synced Oct 10, 2026