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ENER REACH Enerseal
EUDAMEDClass IIb (EU MDR)
Ref OSA23Model OSA23,OSA37,OSA44Ref OSA44 Ref OSA37
Identity
- Trade Name
- ENER REACH Enerseal EUDAMED
- Device Name
- ENER REACH Enerseal EUDAMED
- Model / Reference
- OSA23,OSA37,OSA44 EUDAMEDOSA23 EUDAMEDOSA44 EUDAMEDOSA37 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953815803219 EUDAMED06953815803196 EUDAMED06953815803202 EUDAMED
- Basic UDI-DI
- 69538158Y104TW EUDAMED
- EMDN Code
- K0201010502 LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY HANDPIECES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
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
ENER REACH Enerseal by Reach Surgical, Inc. — Class IIb — 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 | 69538158Y104TW | Class IIb | Active |
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Manufacturer
- Manufacturer
- Reach Surgical, Inc.
- EUDAMED SRN
- CN-MF-000011148
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED ace0f9de-ead7-45b2-981d-bf68f555ec54 61 fields · synced Oct 6, 2026
- EUDAMED bf36dccf-04b7-4034-83f4-fbabd34791d2 61 fields · synced May 16, 2026
- EUDAMED 4df7a270-ab55-4f1d-a0e8-20c9eef79a8e 61 fields · synced May 18, 2026