Identity
- Trade Name
- OPTIO 5 EUDAMED
- Device Name
- Basic Unit Arthro EUDAMED
- Model / Reference
- BU-A EUDAMEDtk39770-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260729830791 EUDAMED
- Basic UDI-DI
- 426072983PRPLH EUDAMED
- EMDN Code
- Z12019007 IRRIGATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Endoscopic spray catheter, single-use
Optio 5 by M.I.S.S. Medizintechnik GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic spray catheter, single-use.
- Spray Catheter — Micro-Tech (Nanjing) Co., Ltd. · Class I
- Measuring Jug 250 — Chaplet International Pvt Ltd · Class I
- IRRIGATION SET SIMPLE WAY — LD Medicare · Class IIa
- Spray Catheter — Micro-Tech (Nanjing) Co., Ltd. · Class I
- RoboClean — Era Endoscopy Srl · Class IIa
- Forceps Jar 30 x 80 — Chaplet International Pvt Ltd · Class I
- Trans Urethral Resection Set (TUR Set) — Poly Medicure Limited · Class IIa
- Measuring Jug 500 — Chaplet International Pvt Ltd · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426072983PRPLH | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- M.I.S.S. Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000020722
Sources (1)
- EUDAMED 53daba89-2380-434d-a4f6-4fb1f72602d3 61 fields · synced Jun 19, 2026