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RETI-port/scan 21 gamma plus²
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 04-99-3.2-JJ1XXXModel alphaRef 04-99-3.2-JJ0XXXModel basicRef 04-99-3.2-JJ8XXXModel delta plusRef 04-99-3.2-JJ4XXXModel beta plusRef 04-99-3.2-JJ3XXXModel betaRef 04-99-3.2-JJ6XXXModel gamma plus
Identity
- Trade Name
- RETI-port/scan 21 EUDAMEDRETI-port/scan 21 gamma plus² FDA UDIRETI-port/scan 21 gamma plus FDA UDIRETI-port/scan 21 alpha FDA UDIRETI-port/scan 21 beta plus FDA UDIRETI-port/scan 21 basic FDA UDIRETI-port/scan 21 delta plus FDA UDIRETI-port/scan 21 beta FDA UDI
- Generic Name
- Electroretinograph FDA UDI
- Device Name
- RETI-port/scan 21 EUDAMED
- Model / Reference
- alpha EUDAMED04-99-3.2-JJ1XXX EUDAMEDbasic EUDAMED04-99-3.2-JJ0XXX EUDAMEDdelta plus EUDAMED04-99-3.2-JJ8XXX EUDAMEDbeta plus EUDAMED04-99-3.2-JJ4XXX EUDAMEDbeta EUDAMED04-99-3.2-JJ3XXX EUDAMEDgamma plus EUDAMED04-99-3.2-JJ6XXX EUDAMED27 FDA UDI26 FDA UDI21 FDA UDI24 FDA UDI20 FDA UDI28 FDA UDI23 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260157780262 EUDAMEDFDA UDI04260157780217 EUDAMEDFDA UDI04260157780248 EUDAMEDFDA UDI04260157780200 EUDAMEDFDA UDI04260157780286 EUDAMEDFDA UDI04260157780231 EUDAMEDFDA UDI04260157780279 FDA UDI
- Basic UDI-DI
- B-04260157780217 EUDAMEDB-04260157780200 EUDAMEDB-04260157780286 EUDAMEDB-04260157780248 EUDAMEDB-04260157780231 EUDAMEDB-04260157780262 EUDAMED
- 510(k) Number
- K023525 FDA UDI
- FDA Product Code
- GWE FDA UDI
- EMDN Code
- V030203 OPHTHALMOLOGY MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Electroretinograph FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1890 FDA UDI
- Market of Registration
- Germany EUDAMEDAustria 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: ElectroretinographElectrooculograph
RETI-port/scan 21 gamma plus² by Roland Consult Stasche & Finger GmbH — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrooculograph.
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Roland Consult Stasche & Finger GmbH
Sources (13)
- FDA UDI 0d0fb5f2-2ab5-4254-a780-2852ed98bf1c 33 fields · synced Jul 24, 2026
- FDA UDI 57475ddd-8be7-488e-bd79-ce6ba492db2b 33 fields · synced May 29, 2026
- FDA UDI 3a6cc424-fa3c-417d-a1b7-7fbc4cd7a8fe 33 fields · synced May 29, 2026
- FDA UDI cab210fa-9ba5-4661-b926-87f0fbd3a32b 33 fields · synced May 30, 2026
- FDA UDI 0f9b4af0-5271-4718-b1b8-a01854c7ad96 33 fields · synced May 30, 2026
- FDA UDI 3185895b-a19f-49d7-91cb-6381fa2f0416 33 fields · synced May 30, 2026
- FDA UDI 04c4548b-2899-43bd-8b4f-049ad3c2df9c 33 fields · synced May 30, 2026
- EUDAMED 7916ed2c-5f2e-45f2-b9bd-dbd5b5aeb9e2 61 fields · synced Jul 9, 2026
- EUDAMED 6349712d-c043-4a4c-966d-cd5c1f42ab1f 61 fields · synced Jul 9, 2026
- EUDAMED d374c965-8ba8-4b4e-9126-d528457f4f3f 61 fields · synced Jul 16, 2026
- EUDAMED fc2cbd71-21a6-457b-b616-15741bd1bbd3 61 fields · synced Jul 17, 2026
- EUDAMED 74fe2d49-9158-45df-b1ea-79eacb4598d1 61 fields · synced Jul 22, 2026
- EUDAMED fdbdee3e-b3f4-4bde-9303-ccb879adafc4 61 fields · synced Jul 24, 2026