Identity
- Model / Reference
- J20007K EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-USMF000023322000009NB EUDAMED
- Basic UDI-DI
- B-USMF000023322000009NB EUDAMED
- EMDN Code
- Z12120299 THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
J20007k by AMO Manufacturing USA, LLC — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-USMF000023322000009NB | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- AMO Manufacturing USA, LLC
- EUDAMED SRN
- US-MF-000023322
- Authorised Representative
- AMO Ireland IE-AR-000013513
Sources (1)
- EUDAMED ae50c8f3-3c28-4fba-be39-beb76caef771 61 fields · synced Jun 18, 2026