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HM Bohrer RA - rund
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref C1S.204.014Model 10521Ref C1SXNZ.204.010Ref C1SXNZ.204.012Ref C1SXNZ.204.023Ref C1SXNZ.204.021
Identity
- Trade Name
- HM Bohrer RA - rund EUDAMEDEDENTA FDA UDI
- Generic Name
- Carbide dental bur, reusable FDA UDI
- Device Name
- HM-/Stahl-Bohrer EUDAMEDTC Bur RA - round FDA UDI
- Model / Reference
- 10521 EUDAMEDC1S.204.014 EUDAMEDFDA UDIC1SXNZ.204.010 EUDAMEDC1SXNZ.204.012 EUDAMEDC1SXNZ.204.023 EUDAMEDC1SXNZ.204.021 EUDAMED
- Description
- TC Bur RA - round FDA UDI
Identifiers
- Catalog Number
- H4S-RA FDA UDI
- Primary DI / UDI-DI
- E312C1S2040141 EUDAMEDFDA UDIE312C1SXNZ2040101 EUDAMEDE312C1SXNZ2040121 EUDAMEDE312C1SXNZ2040231 EUDAMEDE312C1SXNZ2040211 EUDAMED
- Basic UDI-DI
- ++E31210521CQ EUDAMED
- Unit of Use DI
- E312C1S204014101 EUDAMEDE312C1SXNZ204010101 EUDAMEDE312C1SXNZ204012101 EUDAMEDE312C1SXNZ204023101 EUDAMEDE312C1SXNZ204021101 EUDAMED
- FDA Product Code
- EJL FDA UDI
- EMDN Code
- L159007 ODONTOSTOMATOLOGY BURS, REUSABLE EUDAMED
- GMDN Term
- Carbide dental bur, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3240 FDA UDI
- Market of Registration
- Liechtenstein EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
HM Bohrer RA - rund by Edenta Etablissement — Class IIa — 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 | ++E31210521CQ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Edenta Etablissement
- EUDAMED SRN
- LI-MF-000011937
Sources (6)
- EUDAMED fc6d3863-1e21-4a7f-9198-39e6144f2c53 61 fields · synced Aug 4, 2026
- FDA UDI cf4777cb-a493-4fbc-83d9-2c272841edc3 34 fields · synced May 30, 2026
- EUDAMED c171e4b4-0c2e-47aa-bc6a-0c7ad59620dd 61 fields · synced Jul 8, 2026
- EUDAMED 3b87e72f-8273-489d-ade7-e154aba081a1 61 fields · synced Jul 12, 2026
- EUDAMED 85f3382d-7275-49c2-bea9-fd426527a009 61 fields · synced Jul 14, 2026
- EUDAMED fa7b2db4-6b2e-4a6a-aa1e-a806c94b0a58 61 fields · synced Aug 4, 2026