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Bur PM2-MIS 150 diam 3.0 St
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1100501Model PM2 Burs
Identity
- Trade Name
- Bur PM2-MIS 150 diam 3.0 St EUDAMEDBur PM2-MIS D150 diam Ø3.0 St FDA UDI
- Generic Name
- Diamond ENT bur, single-use FDA UDI
- Model / Reference
- PM2 Burs EUDAMED1100501 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 1100501-001 FDA UDI
- Primary DI / UDI-DI
- 17630055506297 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300555_010_ES EUDAMED
- FDA Product Code
- EQJ FDA UDIHBC FDA UDIHBE FDA UDINLY FDA UDIERL FDA UDI
- EMDN Code
- V0199 CUTTING DEVICES, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Diamond ENT bur, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.4140 FDA UDI882.4360 FDA UDI882.4310 FDA UDI874.4250 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Bur PM2-MIS 150 diam 3.0 St by Bien-Air Surgery Sa — 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 | 76300555_010_ES | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Bien-Air Surgery SA
- EUDAMED SRN
- CH-MF-000016376
- Authorised Representative
- Bien-Air Europe Sàrl FR-AR-000011942
Sources (2)
- EUDAMED 0fa1a55c-f1ae-405f-80b5-456e0cd5be6f 61 fields · synced Jun 18, 2026
- FDA UDI 5425a0c8-d3bb-4c02-8fdc-b229ecbad354 33 fields · synced May 30, 2026