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Bur PM2-MIS D150diam C 2.0 St
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1100676Model PM2 Burs
Identity
- Trade Name
- Bur PM2-MIS D150diam C 2.0 St EUDAMEDBur PM2-MIS D150 diam C Ø2.0St FDA UDI
- Generic Name
- Diamond ENT bur, single-use FDA UDI
- Model / Reference
- PM2 Burs EUDAMED1100676 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 1100676-001 FDA UDI
- Primary DI / UDI-DI
- 17630055512069 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
Category: Cranial bur, single-use
Bur PM2-MIS D150diam C 2.0 St by Bien-Air Surgery Sa — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cranial bur, single-use.
- HiCUT Burs — adeor Medical AG · Class II
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- Bone cutters — WILSON (Shanghai) Medical Device Co., Ltd. · Class IIa
- J-Notch Burs — Stryker Instruments · Class IIa
- Bone cutters — WILSON (Shanghai) Medical Device Co., Ltd. · Class IIa
- GT PODO 5 mm rund/round Schaft 2, 35 x 35 — LUKAS-ERZETT GmbH & Co.KG · Class I
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 be11f306-b6fd-4b27-8733-ef6428c796ab 61 fields · synced Aug 2, 2026
- FDA UDI fa2aeedd-2642-4a8c-817b-c4937c77eff8 33 fields · synced May 30, 2026