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Fleks. Dorn
EUDAMEDClass IIa (EU MDR)
Ref IS00900Model Flexible mandrel
by Hpf S.r.l.
Identity
- Trade Name
- FLEKS. DORN EUDAMED
- Model / Reference
- Flexible mandrel EUDAMEDIS00900 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055727373229 EUDAMED
- Basic UDI-DI
- B-08055727373229 EUDAMED
- EMDN Code
- L098001 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY MANDRELS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Drilling power tool attachment, basic
Fleks. Dorn by Hpf S.r.l. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08055727373229 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hpf S.r.l.
- EUDAMED SRN
- IT-MF-000017541
Sources (1)
- EUDAMED 85e79656-6081-4a57-9e89-e2c14dd8d92f 61 fields · synced Jun 18, 2026