Identity
- Device Name
- Metal Suture Anchor EUDAMED
- Model / Reference
- 153750530S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941919231069 EUDAMED
- Basic UDI-DI
- B-06941919231069 EUDAMED
- EMDN Code
- P09120102 ANCHORS, TENDON AND LIGAMENT SYNTHESIS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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: Hand-held surgical retractor, reusable
Metal Suture Anchor by Double Medical Technology Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hand-held surgical retractor, reusable.
- ATLAS — ATLAS CERRAHİ ALETLER LTD. ŞTİ. · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- Gimmi — Gimmi GmbH · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- Sklar® — Sklar Corporation · Class I
- BIOCOMPOSITE PLUS ANCHOR Ø3, 5 MM W/NEEDLE — BMT BAPS BİYO MALZEME SANAYİ VE TİCARET ANONİM ŞİRKETİ · Class III
- Spreizer / Spreader — REDA Instrumente GmbH · Class I
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-06941919231069 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Double Medical Technology Inc.
- EUDAMED SRN
- CN-MF-000009048
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 142d5db1-d00f-4dd2-8bc2-3155d1441ae4 61 fields · synced Jul 11, 2026