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TOP Endoscopic Hood SHL
EUDAMEDClass IIa (EU MDR)
Ref 634125Model SHLRef 634130Model SHL-B
Identity
- Trade Name
- TOP Endoscopic Hood SHL EUDAMEDTOP Endoscopic Hood SHL-B EUDAMED
- Device Name
- TOP Endoscopic Hood EUDAMED
- Model / Reference
- SHL EUDAMED634125 EUDAMEDSHL-B EUDAMED634130 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04996404611422 EUDAMED04996404613167 EUDAMED
- Basic UDI-DI
- B-04996404611422 EUDAMEDB-04996404613167 EUDAMED
- EMDN Code
- G030899 INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Tissue morcellation system handpiece, line-powered
TOP Endoscopic Hood SHL by TOP Corporation — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04996404611422 | Class IIa | Active |
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Manufacturer
- Manufacturer
- TOP Corporation
- EUDAMED SRN
- JP-MF-000011618
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (2)
- EUDAMED b9b22641-6511-43ab-b210-dda09951ddd6 61 fields · synced Jul 27, 2026
- EUDAMED 3b6d1581-1488-47d8-9897-e803cc92f2b4 61 fields · synced May 18, 2026