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Tek-Bal Tibbi̇ Ci̇hazlar San. Ve Ti̇c. Ltd. Şti̇.
EUDAMEDClass IIa (EU MDR)
Ref STR-360
Identity
- Trade Name
- TEK-BAL TIBBİ CİHAZLAR SAN. VE TİC. LTD. ŞTİ. EUDAMED
- Device Name
- 360 Litre Yatay Buharlı Sterilizatör (360 Liter Horizontal Steam Sterilizer) EUDAMED
- Model / Reference
- STR-360 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680659070047 EUDAMED
- Basic UDI-DI
- B-08680659070047 EUDAMED
- EMDN Code
- S9099 STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
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: Sterilizer/disinfector rack
Tek-Bal Tibbi̇ Ci̇hazlar San. Ve Ti̇c. Ltd. Şti̇. by Tek-Bal Tibbi̇ Ci̇hazlar San. Ve Ti̇c. Ltd. Şti̇. — Class IIa — MDD — listed in EUDAMED
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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-08680659070047 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Tek-Bal Tibbi̇ Ci̇hazlar San. Ve Ti̇c. Ltd. Şti̇.
- EUDAMED SRN
- TR-MF-000021319
Sources (1)
- EUDAMED cf38a1e9-da84-4383-8f33-73bbb69faa6c 61 fields · synced Jun 19, 2026