Identity
- Trade Name
- Proctoscope ø 30 mm EUDAMEDApplicator ø 24 mm, for Proctoscope ø 30 mm EUDAMED
- Device Name
- MAASTRO Rectal Applicator Set EUDAMED
- Model / Reference
- GM11014220 EUDAMEDGM11014210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816389028166 EUDAMED00816389028159 EUDAMED
- Basic UDI-DI
- 089947500201005PL EUDAMED
- Direct Marketing DI
- 00816389028159 EUDAMED
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Proctoscope ø 30 mm by Varian Medical Systems, Inc — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 089947500201005PL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000001784
- Authorised Representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Sources (2)
- EUDAMED 0927ad82-cb90-40c7-a7b5-e3e38b9833df 61 fields · synced Aug 4, 2026
- EUDAMED 9a4214f6-1285-4f3b-a61c-93f5cec34170 61 fields · synced May 17, 2026