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Hysteroscope
EUDAMEDClass IIa (EU MDR)
Ref 8300039616Ref 8300067442Ref 8300012542Ref 8300067444Ref 8300009035Ref 8300037064Ref 8300067440Ref 8300009025Ref 8300067445Ref 8300052280Ref 8300052060Ref 8300059314Ref 8300059316Ref 8300059308Ref 8300067443Ref 8300009030Ref 8300059312
Identity
- Trade Name
- HYSTEROSCOPE EUDAMED
- Device Name
- Hysteroscope EUDAMED
- Model / Reference
- 8300039616 EUDAMED8300067442 EUDAMED8300012542 EUDAMED8300067444 EUDAMED8300009035 EUDAMED8300037064 EUDAMED8300067440 EUDAMED8300009025 EUDAMED8300067445 EUDAMED8300052280 EUDAMED8300052060 EUDAMED8300059314 EUDAMED8300059316 EUDAMED8300059308 EUDAMED8300067443 EUDAMED8300009030 EUDAMED8300059312 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04035873065494 EUDAMED04035873078050 EUDAMED04035873064312 EUDAMED04035873078074 EUDAMED04035873064367 EUDAMED04035873065487 EUDAMED04035873078036 EUDAMED04035873064343 EUDAMED04035873078081 EUDAMED04035873076599 EUDAMED04035873076605 EUDAMED04035873076520 EUDAMED04035873076537 EUDAMED04035873076506 EUDAMED04035873078067 EUDAMED04035873064350 EUDAMED04035873076513 EUDAMED
- Basic UDI-DI
- 4035873120101059Y EUDAMED
- Direct Marketing DI
- 04035873065494 EUDAMED04035873078050 EUDAMED04035873064312 EUDAMED04035873078074 EUDAMED04035873064367 EUDAMED04035873065487 EUDAMED04035873078036 EUDAMED04035873064343 EUDAMED04035873078081 EUDAMED04035873076599 EUDAMED04035873076605 EUDAMED04035873076520 EUDAMED04035873076537 EUDAMED04035873076506 EUDAMED04035873078067 EUDAMED04035873064350 EUDAMED04035873076513 EUDAMED
- EMDN Code
- Z12020704 HYSTEROSCOPES 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Rigid video hysteroscope
Hysteroscope by Henke-Sass, Wolf GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Rigid video hysteroscope.
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- Hys. 027.00.3020a 40k — Blazejewski MEDI-TECH GmbH · Class IIa
- Single-use Digital Hysteroscope — Zhejiang Geyi Medical Instrument Co., Ltd. · Class IIa
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- Hystéroscope à Usage Unique HTx — Suzhou AcuVu Medical Technology Co., Ltd. · Class IIa
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 | 4035873120101059Y | Class IIa | Active |
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Manufacturer
- Manufacturer
- Henke-Sass, Wolf GmbH
- EUDAMED SRN
- DE-MF-000005531
Sources (17)
- EUDAMED a952dd13-3f06-4ca8-85c2-64a334ec946f 61 fields · synced Oct 6, 2026
- EUDAMED f9afac6b-5006-4c4b-accc-c28663401136 61 fields · synced May 16, 2026
- EUDAMED 303b898d-7192-4595-8b59-85ba0d088c63 61 fields · synced May 17, 2026
- EUDAMED ec9d8c4a-51aa-46da-aac1-9a71e7aefa8a 61 fields · synced May 17, 2026
- EUDAMED 6b91e765-07a9-4c3a-adf8-ccf53c17dd40 61 fields · synced May 17, 2026
- EUDAMED 573e0236-a936-4475-9e59-9586e75fe76c 61 fields · synced May 17, 2026
- EUDAMED 540bd1e7-33b6-4d02-9fb6-b28694307a6e 61 fields · synced May 17, 2026
- EUDAMED dd0213e5-7627-4f5c-bbf3-d289774a77f5 61 fields · synced May 17, 2026
- EUDAMED 11fde484-f52c-4745-b391-221c0bd429c1 61 fields · synced May 17, 2026
- EUDAMED 953a0a7a-c4da-4613-94e4-f3765f8cac88 61 fields · synced May 18, 2026
- EUDAMED 9163fb37-a5ba-4300-8698-51d7296835a2 61 fields · synced May 18, 2026
- EUDAMED 0a41ce8a-62ff-4197-9b14-681f2b97bd71 61 fields · synced May 18, 2026
- EUDAMED 147c60ee-0061-4458-ae32-a2ef7a68999b 61 fields · synced May 18, 2026
- EUDAMED ef9a7d6b-0ba5-4aa8-b24e-74e2966e3f75 61 fields · synced May 18, 2026
- EUDAMED 53a32b4b-75b4-4345-b802-cc98af00ca70 61 fields · synced May 18, 2026
- EUDAMED 50f6c340-176b-4084-9e95-a65406514c81 61 fields · synced Jul 9, 2026
- EUDAMED e99eea77-ffdc-47fd-a673-8b7118921dc9 61 fields · synced Jul 10, 2026