Identity
- Trade Name
- APOLLO blue line EUDAMEDAPOLLO FDA UDI
- Generic Name
- Laser patient positioning system FDA UDI
- Device Name
- Laser patient positioning system EUDAMED
- Model / Reference
- 0014621-0008 EUDAMEDAPOLLO blue line FDA UDI
Identifiers
- Catalog Number
- 0014621-0008 FDA UDI
- Primary DI / UDI-DI
- 04260590370075 EUDAMEDFDA UDI
- Basic UDI-DI
- 426059037PATPOSLASERCR EUDAMED
- FDA Product Code
- IWE FDA UDI
- EMDN Code
- Z119010 LASER SYSTEMS FOR PATIENT POSITIONING EUDAMED
- GMDN Term
- Laser patient positioning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.5780 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Laser patient positioning system
APOLLO blue line by LAP GmbH Laser Applikationen — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 426059037PATPOSLASERCR | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- LAP GmbH Laser Applikationen
- EUDAMED SRN
- DE-MF-000005792
Sources (2)
- EUDAMED 46bb6bdb-6658-4273-b919-c4db18a1fb72 61 fields · synced Jun 19, 2026
- FDA UDI 16a31abc-1392-42a2-8d36-e8ee755497b1 33 fields · synced May 30, 2026