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Dorc Cryostar Single Use Probe Adaptor
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2509-P-8036
by Keeler Ltd
Identity
- Trade Name
- DORC CRYOSTAR SINGLE USE PROBE ADAPTOR EUDAMEDDORC CRYOSTAR ADAPTOR FDA UDI
- Generic Name
- Ophthalmic cryosurgical system, electronic FDA UDI
- Device Name
- DORC CRYOSTAR SINGLE USE PROBE ADAPTOR EUDAMED
- Model / Reference
- 2509-P-8036 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055272721424 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055272721424 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 I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4170 FDA UDI
- Market of Registration
- Spain 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dorc Cryostar Single Use Probe Adaptor by Keeler Ltd — Class I — 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-05055272721424 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 (3)
- EUDAMED e364a180-93a6-4fbd-8696-46682f86cba2 61 fields · synced Jul 29, 2026
- FDA UDI 0590858e-af0d-4fe9-b61a-47cdc0fb40ed 32 fields · synced May 30, 2026
- EUDAMED fadf7fd5-20c2-4ba1-9c6e-60301d94708e 61 fields · synced Jul 29, 2026