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ACETABULAR REAMER EVO 2 D55 mm
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref H0036555599Model ACETABULAR REAMER EVO 2
by Hpf Srl
Identity
- Trade Name
- ACETABULARRIVAL EVO 2 D55 mm EUDAMEDACETABULAR REAMER EVO 2 D55 mm FDA UDI
- Generic Name
- Acetabular orthopaedic reamer FDA UDI
- Model / Reference
- H0036555599 EUDAMEDFDA UDIACETABULAR REAMER EVO 2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057968716094 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08057968716094 EUDAMED
- FDA Product Code
- HWE FDA UDI
- EMDN Code
- P091301 ORTHOPAEDIC IMPLANT REAMERS, SINGLE-USE EUDAMED
- GMDN Term
- Acetabular orthopaedic reamer 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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: Acetabular orthopaedic reamer
ACETABULAR REAMER EVO 2 D55 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 9c61654d-dbdf-4e83-8877-c25779687df3 32 fields · synced Jul 12, 2026
- EUDAMED 09fd21c6-2beb-4dde-a5ee-623bafde4f38 61 fields · synced Jun 14, 2026