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Fixation for 3-channel applicators, for adjustable holder
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref GM11001280
Identity
- Trade Name
- Fixation for 3-channel applicators, for adjustable holder EUDAMEDFixation for 3 channel applicators, for adjustable holder FDA UDIFixation for three channel applicators for adjustable holder FDA UDI
- Generic Name
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Fixation for 3-channel applicators EUDAMEDfor Fletcher-style Applicator Sets and Universal Endometrial Applicator Set FDA UDI
- Model / Reference
- GM11001280 EUDAMEDFDA UDI
- Description
- for Fletcher-style Applicator Sets and Universal Endometrial Applicator Set FDA UDI
Identifiers
- Catalog Number
- GM11001280 FDA UDI
- Primary DI / UDI-DI
- 00810563022483 EUDAMEDFDA UDI00816389021976 FDA UDI
- Basic UDI-DI
- 089947500201090Q5 EUDAMED
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5700 FDA UDI
- Market of Registration
- Netherlands 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
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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDIFDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Fixation for 3-channel applicators, for adjustable holder by Varian Medical Systems, Inc — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 089947500201090Q5 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (3)
- EUDAMED e880ad2f-0abf-4e7a-8ff1-132cbbcb9ece 61 fields · synced Jul 18, 2026
- FDA UDI 9ac7f87f-fa76-4449-b82b-87c925fb8921 34 fields · synced May 30, 2026
- FDA UDI eacbf64a-f604-46c0-a92d-c8249cf2c59b 35 fields · synced May 30, 2026