← Back to catalogue
Intelligent Handles
EUDAMEDClass IIa (EU MDR)
Ref IDRCOREModel IDRCORE, IDRCORE-0, Accessories: IDRBATTERY, IDRCHARGER, IDRTOOL.
Identity
- Trade Name
- Intelligent Handles EUDAMED
- Device Name
- LINEAR STAPLERS FOR VIDEOSURGERY / LINEAR STAPLERS, OPEN SURGERY EUDAMED
- Model / Reference
- IDRCORE, IDRCORE-0, Accessories: IDRBATTERY, IDRCHARGER, IDRTOOL. EUDAMEDIDRCORE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953815860007 EUDAMED
- Basic UDI-DI
- 69538158BF00RR EUDAMED
- EMDN Code
- H0202010199,H02030199 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Intelligent Handles by Reach Surgical, Inc. — Class IIa — 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 | 69538158BF00RR | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Reach Surgical, Inc.
- EUDAMED SRN
- CN-MF-000011148
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED d0a63fe1-f23c-4052-8796-ae706bffdce2 61 fields · synced Oct 6, 2026