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Drill
EUDAMEDClass IIa (EU MDR)
Ref FG2102Model FG2100, FG2101, FG2102, KMC-011-00, KMC-011-01, KMC-012-00Ref FG2100
Identity
- Device Name
- Drill EUDAMED
- Model / Reference
- FG2100, FG2101, FG2102, KMC-011-00, KMC-011-01, KMC-012-00 EUDAMEDFG2102 EUDAMEDFG2100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938695502230 EUDAMED06938695521026 EUDAMED
- Basic UDI-DI
- 69386955KT03ZW EUDAMED
- Direct Marketing DI
- 06938695502230 EUDAMED06938695521026 EUDAMED
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Drill by Shanghai Kinetic Medical Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69386955KT03ZW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shanghai Kinetic Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000017688
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED 49024db6-7948-4e5e-97bf-e0886c75c246 61 fields · synced Oct 6, 2026
- EUDAMED fc0e4fb6-e1fa-4731-a337-93704a0a9ed9 61 fields · synced May 17, 2026