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Planmeca Compact i5
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 30013450
by Planmeca Oy
Identity
- Trade Name
- Planmeca Compact i5 EUDAMEDPlanmeca Compact FDA UDI
- Generic Name
- Dental delivery system FDA UDI
- Device Name
- Planmeca Compact i EUDAMEDPlanmeca Compact i5 is a dental operative unit including a dental patient chair. The unit is equipped with a digital control system and a user interface with a touch panel. The instrument console includes five instrument locations, with easy instrument change. FDA UDI
- Model / Reference
- 30013450 EUDAMEDi5 FDA UDI
- Description
- Planmeca Compact i5 is a dental operative unit including a dental patient chair. The unit is equipped with a digital control system and a user interface with a touch panel. The instrument console includes five instrument locations, with easy instrument change. FDA UDI
Identifiers
- Catalog Number
- 30013450, 30015629, 30015630, 30015632, 30015633 FDA UDI
- Primary DI / UDI-DI
- 06430035420575 EUDAMEDFDA UDI
- Basic UDI-DI
- 6430035420075R EUDAMED
- 510(k) Number
- K961420 FDA UDI
- FDA Product Code
- EIA FDA UDI
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
- GMDN Term
- Dental delivery system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Market of Registration
- Finland 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Planmeca Compact i5 by Planmeca Oy — 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 | 6430035420075R | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Planmeca Oy
- EUDAMED SRN
- FI-MF-000006499
Sources (2)
- EUDAMED c10f39e1-4f9a-4d9b-9542-ff333c909fbe 61 fields · synced Jun 18, 2026
- FDA UDI e2d73d6e-d833-479a-a370-0ebb4b1b9595 35 fields · synced May 30, 2026