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Flex. Mandrel Coated Black
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref H0010051199Model Flexible mandrel (silicone)
by Hpf Srl
Identity
- Trade Name
- FLEKS. DORN BELAGT MED SORT EUDAMEDFLEX. MANDREL COATED BLACK FDA UDI
- Generic Name
- Drilling power tool attachment, basic FDA UDI
- Model / Reference
- H0010051199 EUDAMEDFDA UDIFlexible mandrel (silicone) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057968711518 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08057968711518 EUDAMED
- FDA Product Code
- HWE FDA UDI
- EMDN Code
- L098001 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY MANDRELS, REUSABLE EUDAMED
- GMDN Term
- Drilling power tool attachment, basic 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
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: Drilling power tool attachment, basic
Flex. Mandrel Coated Black 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 cd9ca33f-5c9f-4f21-8144-34f455df4ad4 32 fields · synced Jul 9, 2026
- EUDAMED 826966bb-ba07-4be0-8635-32b00bcf630f 61 fields · synced Jul 9, 2026