Identity
- Trade Name
- Ophthalmed® laser probe EUDAMEDNA FDA UDI
- Generic Name
- Ophthalmic laser system beam guide FDA UDI
- Device Name
- ILLUMINATED LASER PROBE 25g BENDING TIP WITH LASER QUANTEL SUPRA VITRA DIRECT CONNECTION AND ILLUMINATION DORC EVA EUDAMED
- Model / Reference
- B509604 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811682037211 EUDAMEDM735B5096041 FDA UDI
- Basic UDI-DI
- B-00811682037211 EUDAMED
- 510(k) Number
- K142830 FDA UDI
- FDA Product Code
- HQB FDA UDI
- EMDN Code
- Q02040301 OCULAR ENDOPHOTOCOAGULATION FIBERS, SINGLE-USE EUDAMED
- GMDN Term
- Ophthalmic laser system beam guide FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4690 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 25 Gauge FDA UDI
Ophthalmed® laser probe by Ophthalmed Llc — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00811682037211 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Ophthalmed Llc
- EUDAMED SRN
- US-MF-000032432
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED d2eaa596-fc63-431b-8aa7-d8f4777b82ea 61 fields · synced Jul 22, 2026
- FDA UDI 27a11f95-061b-4836-acee-c182bc75a7bd 35 fields · synced May 29, 2026