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Binocular Loupes
EUDAMEDClass I (EU MDR)
Ref CF001Model CLM H series, CLM G series, CLF H series, CLF G series, TTL series, DY seriesRef 2.5X-520mm(Headband Type)Model SC H series, SC G series, SC TTL seriesRef 2.5X-460mm(TTL)Ref 3X-520mm(Headband Type)Ref 2.5X-420mm(Headband Type)Ref 3X-500mm(Extended field-of-view Headband Type)Ref 3.5X-420mm(Headband Type)Ref 2.5X-500mm(Extended field-of-view Glass Type)Ref 3X-520mm(Glass Type)Ref 3X-460mm(Extended field-of-view Headband Type)Ref 2.5X-420mm(Glass Type)Ref 2.5X-460mm(Extended field-of-view Headband Type)Ref 3.5X-520mm(Glass Type)Ref 3X-500mm(Extended field-of-view Glass Type)Ref 2.5X-420mm(Extended field-of-view Headband Type)Ref 3.5X-420mm(Glass Type)Ref 2.5X-420mm(Extended field-of-view Glass Type)Ref 3X-420mm(Headband Type)Ref SC2.5X-520JRef 2.5X-500mm(Extended field-of-view Headband Type)Ref 3X-340mm(Extended field-of-view Headband Type)
Identity
- Trade Name
- Binocular Loupes EUDAMED
- Device Name
- Binocular Loupes EUDAMED
- Model / Reference
- CLM H series, CLM G series, CLF H series, CLF G series, TTL series, DY series EUDAMEDCF001 EUDAMEDSC H series, SC G series, SC TTL series EUDAMED2.5X-520mm(Headband Type) EUDAMED2.5X-460mm(TTL) EUDAMED3X-520mm(Headband Type) EUDAMED2.5X-420mm(Headband Type) EUDAMED3X-500mm(Extended field-of-view Headband Type) EUDAMED3.5X-420mm(Headband Type) EUDAMED2.5X-500mm(Extended field-of-view Glass Type) EUDAMED3X-520mm(Glass Type) EUDAMED3X-460mm(Extended field-of-view Headband Type) EUDAMED2.5X-420mm(Glass Type) EUDAMED2.5X-460mm(Extended field-of-view Headband Type) EUDAMED3.5X-520mm(Glass Type) EUDAMED3X-500mm(Extended field-of-view Glass Type) EUDAMED2.5X-420mm(Extended field-of-view Headband Type) EUDAMED3.5X-420mm(Glass Type) EUDAMED2.5X-420mm(Extended field-of-view Glass Type) EUDAMED3X-420mm(Headband Type) EUDAMEDSC2.5X-520J EUDAMED2.5X-500mm(Extended field-of-view Headband Type) EUDAMED3X-340mm(Extended field-of-view Headband Type) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972933622335 EUDAMED06972933620188 EUDAMED06972933622069 EUDAMED06972933622328 EUDAMED06972933622298 EUDAMED06972933624476 EUDAMED06972933622311 EUDAMED06972933622021 EUDAMED06972933621369 EUDAMED06972933622342 EUDAMED06972933620645 EUDAMED06972933621130 EUDAMED06972933624407 EUDAMED06972933622304 EUDAMED06972933624513 EUDAMED06972933624384 EUDAMED06972933622052 EUDAMED06972933620621 EUDAMED06972933624421 EUDAMED06972933621192 EUDAMED
- Basic UDI-DI
- 697293362CF001D8 EUDAMED
- EMDN Code
- L1099 MICROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Binocular Loupes by Chamfond Biotech Co., Ltd — Class I — 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 | 697293362CF001D8 | Class I | Active |
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Manufacturer
- Manufacturer
- Chamfond Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000024191
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (28)
- EUDAMED 0143f8fb-2d57-400d-9f47-cd1faddefd32 61 fields · synced Sep 18, 2026
- EUDAMED 56dd84a5-1c26-4239-89b4-5d18b0ee3324 61 fields · synced May 17, 2026
- EUDAMED cb6fcfc9-329e-4e64-bbcf-c5f16bc09a10 61 fields · synced May 17, 2026
- EUDAMED e306234c-f3f2-42d7-8ee3-235440bcbea1 61 fields · synced May 17, 2026
- EUDAMED 7f94efd7-8bbc-4b57-82b7-f5759cfb0bf7 61 fields · synced May 18, 2026
- EUDAMED 2641044b-f7b3-4507-a329-8cde295171fe 61 fields · synced May 19, 2026
- EUDAMED db9b5e4e-a05b-43ee-a16d-ef58c377b89f 61 fields · synced May 19, 2026
- EUDAMED 0746dcb7-0ad5-4c58-8315-c2753e75199e 61 fields · synced May 19, 2026
- EUDAMED 0a45239a-04cb-4b14-9906-3762a0394b5a 61 fields · synced Jun 20, 2026
- EUDAMED 5318f8c6-04e7-4574-940d-513f48114c8d 61 fields · synced Jul 10, 2026
- EUDAMED bbed905a-1c12-424a-8946-52d01651d084 61 fields · synced Jul 11, 2026
- EUDAMED c7b67f09-cb49-4f21-a503-3ae4922e3967 61 fields · synced Jul 11, 2026
- EUDAMED 0402df90-f7fc-42f3-8c36-f78f9a6b8e81 61 fields · synced Jul 11, 2026
- EUDAMED de49e653-1061-4d00-99d8-a660dd95aca4 61 fields · synced Jul 11, 2026
- EUDAMED 08d3efca-b4fd-42a5-9fa5-bae0da5d7c87 61 fields · synced Jul 13, 2026
- EUDAMED 0db717da-de0c-4654-9ff9-7e10c69c4d10 61 fields · synced Jul 14, 2026
- EUDAMED ffb2f396-2da1-4a7b-a09a-2032491d7828 61 fields · synced Jul 17, 2026
- EUDAMED db5fd89a-cf1f-4ceb-8a08-6b30d3604085 61 fields · synced Jul 17, 2026
- EUDAMED ef24039c-c40b-4d75-a780-b1a6c2fe02a0 61 fields · synced Jul 19, 2026
- EUDAMED da8671ed-2952-421c-8043-2977b371fcfc 61 fields · synced Jul 24, 2026
- EUDAMED 27875c90-8285-4756-9160-0bbb507b7cdc 61 fields · synced Jul 24, 2026
- EUDAMED 25e79b1b-4bf7-4b13-b2e9-f524e0832951 61 fields · synced Jul 25, 2026
- EUDAMED 7414099f-a16d-45b3-b2a3-1d624610b80d 61 fields · synced Jul 26, 2026
- EUDAMED 51c6a653-2d21-4593-bc23-c82a954e600c 61 fields · synced Jul 28, 2026
- EUDAMED 274139ee-4f6e-4ec0-8f02-b354a2c16520 61 fields · synced Jul 30, 2026
- EUDAMED d1cc8e0e-2407-41e0-9939-7b0d1f08c12a 61 fields · synced Aug 1, 2026
- EUDAMED 00e1e013-00b8-4076-a7ab-ec74de395e07 61 fields · synced Aug 2, 2026
- EUDAMED 8f9ab473-6c00-4728-9e56-26611bdd386f 61 fields · synced Sep 18, 2026