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CUP IMPACTOR 4.0 M8x1
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref H0034300099Model Cup impactors 4.0
by Hpf Srl
Identity
- Trade Name
- KOP IMPACTOR 4.0 M8x1 EUDAMEDCUP IMPACTOR 4.0 M8x1 FDA UDI
- Generic Name
- Orthopaedic implant impactor, reusable FDA UDI
- Model / Reference
- H0034300099 EUDAMEDFDA UDICup impactors 4.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057968716940 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08057968716940 EUDAMED
- FDA Product Code
- HWA FDA UDI
- EMDN Code
- L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic implant impactor, reusable 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: Orthopaedic implant impactor, reusable
CUP IMPACTOR 4.0 M8x1 by Hpf Srl — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Orthopaedic implant impactor, reusable.
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- R3 — Smith & Nephew, Inc. · Class I
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 17d8885e-59ab-41b9-b11f-833801b3b061 32 fields · synced Jul 25, 2026
- EUDAMED 874b2a93-a42b-48fd-9327-a61d98d613d1 61 fields · synced Jul 25, 2026