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Cryomatic Mkii Standard Retinal Pencil
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 2509-P-8020
by Keeler Ltd
Identity
- Trade Name
- CRYOMATIC MKII STANDARD RETINAL PENCIL EUDAMEDFDA UDI
- Generic Name
- Ophthalmic cryosurgical system, electronic FDA UDI
- Device Name
- CRYOMATIC MKII STANDARD RETINAL PENCIL EUDAMED
- Model / Reference
- 2509-P-8020 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055272711760 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055272711760 EUDAMED
- FDA Product Code
- HRN FDA UDI
- EMDN Code
- L1705 OPHTHALMOLOGY PROBES, REUSABLE EUDAMED
- GMDN Term
- Ophthalmic cryosurgical system, electronic FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4170 FDA UDI
- Market of Registration
- Sweden 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Cryomatic Mkii Standard Retinal Pencil by Keeler Ltd — Class IIb — 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-05055272711760 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 9098b5c4-ecde-4e8d-a255-19329d900a93 61 fields · synced Jun 17, 2026
- FDA UDI ed342648-1302-4244-a76f-2e68e0b5f09f 32 fields · synced May 30, 2026