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TRIAL HEAD D28 mm
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref H0050051500Model Trial head
by Hpf Srl
Identity
- Trade Name
- ZKUŠEBNÍ HLAVA D28 mm EUDAMEDTRIAL HEAD D28 mm FDA UDI
- Generic Name
- Femoral head prosthesis trial FDA UDI
- Model / Reference
- H0050051500 EUDAMEDFDA UDITrial head EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057968713673 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08057968713673 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- V06010101 HIP PROSTHESES TESTING DEVICES EUDAMED
- GMDN Term
- Femoral head prosthesis trial FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Femoral head prosthesis trial
TRIAL HEAD D28 mm by Hpf Srl — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hpf Srl
Sources (2)
- FDA UDI 806595ac-8cbd-4214-8b97-4fd79fa58c37 32 fields · synced Jul 22, 2026
- EUDAMED b36956a0-c96f-4613-9f73-5d8b1700ec9b 61 fields · synced Jul 22, 2026