ACETABULAR REAMER EVO 2 Ti CUP D56 mm
FDA UDIEUDAMEDClass I (US FDA UDI)
by Hpf Srl
Identity
- Trade Name
- ACETABULARRIVAL EVO 2 Ti KOP D56 mm EUDAMEDACETABULAR REAMER EVO 2 Ti CUP D56 mm FDA UDI
- Generic Name
- Bone-resection orthopaedic reamer, single-use FDA UDI
- Model / Reference
- H0038555699 EUDAMEDFDA UDIACETABULAR REAMER EVO 2 Ti CUP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057968717725 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08057968717725 EUDAMED
- FDA Product Code
- HWE FDA UDI
- EMDN Code
- P091301 ORTHOPAEDIC IMPLANT REAMERS, SINGLE-USE EUDAMED
- GMDN Term
- Bone-resection orthopaedic reamer, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
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
No
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: Bone-resection orthopaedic reamer, single-use
ACETABULAR REAMER EVO 2 Ti CUP D56 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
MDD
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 4d0638d6-2c0f-4e56-afeb-5ec360d51d69 32 fields · synced Jul 21, 2026
- EUDAMED 0ba885b3-36ff-462f-9907-28c521bf3e5a 61 fields · synced Jul 21, 2026