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Applicator and Dilator for Proctoscope ø30 mm
EUDAMEDClass IIa (EU MDR)
Ref GM11014410
Identity
- Trade Name
- Applicator and Dilator for Proctoscope ø30 mm EUDAMED
- Device Name
- MAASTRO Rectal Applicator Set EUDAMED
- Model / Reference
- GM11014410 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816389020207 EUDAMED
- Basic UDI-DI
- 089947500201005PL 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
Applicator and Dilator for Proctoscope ø30 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 (1)
- EUDAMED 8c917c37-859a-4b38-87a1-19f522a39969 61 fields · synced Jun 18, 2026