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4500176722025
EUDAMEDFDA UDIClass I (EU MDR)
Ref 4500176722025Model Surgical hand-held instruments
Identity
- Trade Name
- n/a FDA UDI
- Generic Name
- Manual endodontic file/rasp, reusable FDA UDI
- Device Name
- Instrument for endodontic application FDA UDI
- Model / Reference
- Surgical hand-held instruments EUDAMED4500176722025 EUDAMED176 025 FDA UDI
- Description
- Instrument for endodontic application FDA UDI
Identifiers
- Catalog Number
- 340814655453025 FDA UDI
- Primary DI / UDI-DI
- E0HM45001767220251 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E0HM209I03AHQ5 EUDAMED
- FDA Product Code
- EKS FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Manual endodontic file/rasp, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany 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
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
4500176722025 by Hager & Meisinger GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E0HM209I03AHQ5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hager & Meisinger GmbH
- EUDAMED SRN
- DE-MF-000004966
Sources (2)
- EUDAMED 7ffcd7a7-dd64-4f9c-87d9-fadcc6c85bdf 61 fields · synced Oct 5, 2026
- FDA UDI 8f05fdf2-fb21-4f0f-b25d-b1962686fb12 35 fields · synced May 30, 2026