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Single Use Retinal Cryo Probe (box Of 10 Probes)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2509-P-8033
by Keeler Ltd
Identity
- Trade Name
- SINGLE USE RETINAL CRYO PROBE (BOX OF 10 PROBES) EUDAMEDFDA UDI
- Generic Name
- Ophthalmic cryosurgical system, electronic FDA UDI
- Device Name
- SINGLE USE RETINAL CYRO PROBE EUDAMED
- Model / Reference
- 2509-P-8033 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055272720113 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055272720113 EUDAMED
- FDA Product Code
- HRN FDA UDI
- EMDN Code
- Z120102 CRYOSURGERY EQUIPMENT EUDAMED
- GMDN Term
- Ophthalmic cryosurgical system, electronic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4170 FDA UDI
- Market of Registration
- Austria 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Single Use Retinal Cryo Probe (box Of 10 Probes) by Keeler Ltd — 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-05055272720113 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Keeler Ltd
- EUDAMED SRN
- GB-MF-000009031
- Authorised Representative
- Keeler Europe Distribution, S.L. ES-AR-000001559
Sources (2)
- EUDAMED 8b04d7fc-b19e-4cc8-b0e8-6867348486b7 61 fields · synced Jun 19, 2026
- FDA UDI fc65a0d2-5df8-4c63-bb68-246bb8bcd12d 32 fields · synced May 30, 2026