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Planning foil
EUDAMEDClass I (EU MDR)
Ref K5300.9017Ref K5300.9016
by ALTATEC GmbH
Identity
- Trade Name
- Planning foil EUDAMED
- Device Name
- X-Ray planning foil EUDAMED
- Model / Reference
- K5300.9017 EUDAMEDK5300.9016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04099797018851 EUDAMED04099797018844 EUDAMED
- Basic UDI-DI
- 40997970008010000000000H8 EUDAMED
- Secondary DI
- E219k530090171 EUDAMEDE219k530090161 EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Planning foil by ALTATEC GmbH — Class I — 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 | 40997970008010000000000H8 | Class I | Active |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
- EUDAMED SRN
- DE-MF-000006230
Sources (2)
- EUDAMED 47dd9492-8076-421e-af15-376212685843 61 fields · synced Jul 30, 2026
- EUDAMED 27e6bd52-183e-45c9-99c2-b1217487f3bf 61 fields · synced May 18, 2026