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Tek-Bal Tibbi̇ Ci̇hazlar San. Ve Ti̇c. Ltd. Şti̇.
EUDAMEDClass IIa (EU MDR)
Ref STR-160Ref STRV-50Ref STR-1000Ref STRD-V90Ref STRD-100Ref STRD-130Ref STR-500Ref STRD-800Ref STR-1200Ref STRD-18Ref STRD-50Ref STRV-90Ref STRD-1000Ref STR-23Ref STR-1100Ref STR-300Ref STRD-30Ref STRV-75Ref STR-130Ref STR-800Ref STRD-450Ref STRD-160Ref STR-V130Ref STRD-500Model STRD-500 Ref STR-30Ref STR-50Ref STRD-300
Identity
- Trade Name
- TEK-BAL TIBBİ CİHAZLAR SAN. VE TİC. LTD. ŞTİ. EUDAMEDTEK-BAL TIBBİ CİHAZLAR SAN. VE TİC. LTD. ŞTİ. ( EUDAMED
- Device Name
- 130 Litre Yatay Buharlı Sterilizatör (130 Liter Horizontal Steam Sterilizer) EUDAMED50 Litre Dik Tip Buharlı Sterilizatör (50 Liter Vertical Steam Sterilizer) EUDAMED1000 Litre Yatay Buharlı Sterilizatör (1000 Liter Horizontal Steam Sterilizer) EUDAMED90 Litre Dik Tip Buharlı Sterilizatör (90 Liter Vertical Steam Sterilizer) EUDAMED100 Litre Yatay Buharlı Sterilizatör (100 Liter Horizontal Steam Sterilizer) EUDAMED500 Litre Yatay Buharlı Sterilizatör (500 Liter Horizontal Steam Sterilizer) EUDAMED800 Litre Yatay Buharlı Sterilizatör (800 Liter Horizontal Steam Sterilizer) EUDAMED1200 Litre Yatay Buharlı Sterilizatör (1200 Liter Horizontal Steam Sterilizer) EUDAMED18 Litre Masaüstü Buharlı Sterilizatör (18L Desktop Steam Sterilizer) EUDAMED50 Litre Masaüstü Buharlı Sterilizatör (50 Liter Desktop Steam Sterilizer) EUDAMEDMasaüstü Buharlı Sterilizatör 23 litre (Desktop Steam Sterilizer 23 liters) EUDAMED1100 Litre Yatay Buharlı Sterilizatör (1100 Liter Horizontal Steam Sterilizer) EUDAMED300 Litre Yatay Buharlı Sterilizatör (300 Liter Horizontal Steam Sterilizer) EUDAMED30 Litre Masaüstü Buharlı Sterilizatör (30 Liter Desktop Steam Sterilizer) EUDAMED75 Litre Dik Tip Buharlı Sterilizatör (75 Liter Vertical Steam Sterilizer) EUDAMED450 Litre Yatay Buharlı Sterilizatör (450 Liter Horizontal Steam Sterilizer) EUDAMED160 Litre Yatay Buharlı Sterilizatör (160 Liter Horizontal Steam Sterilizer) EUDAMED130 Litre Dik Tip Buharlı Sterilizatör (130 Liter Vertical Steam Sterilizer) EUDAMED
- Model / Reference
- STR-160 EUDAMEDSTRV-50 EUDAMEDSTR-1000 EUDAMEDSTRD-V90 EUDAMEDSTRD-100 EUDAMEDSTRD-130 EUDAMEDSTR-500 EUDAMEDSTRD-800 EUDAMEDSTR-1200 EUDAMEDSTRD-18 EUDAMEDSTRD-50 EUDAMEDSTRV-90 EUDAMEDSTRD-1000 EUDAMEDSTR-23 EUDAMEDSTR-1100 EUDAMEDSTR-300 EUDAMEDSTRD-30 EUDAMEDSTRV-75 EUDAMEDSTR-130 EUDAMEDSTR-800 EUDAMEDSTRD-450 EUDAMEDSTRD-160 EUDAMEDSTR-V130 EUDAMEDSTRD-500 EUDAMEDSTR-30 EUDAMEDSTR-50 EUDAMEDSTRD-300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680659070313 EUDAMED08680659070085 EUDAMED08680659070276 EUDAMED08680659070252 EUDAMED08680659070283 EUDAMED08680659070290 EUDAMED08680659070450 EUDAMED08680659070405 EUDAMED08680659070184 EUDAMED08680659070191 EUDAMED08680659070238 EUDAMED08680659070108 EUDAMED08680659070429 EUDAMED08680659070177 EUDAMED08680659070153 EUDAMED08680659070139 EUDAMED08680659070221 EUDAMED08680659070092 EUDAMED08680659070023 EUDAMED08680659070122 EUDAMED08680659070375 EUDAMED08680659070337 EUDAMED08680659070115 EUDAMED08680659070467 EUDAMED08680659070078 EUDAMED08680659070214 EUDAMED08680659070351 EUDAMED
- Basic UDI-DI
- B-08680659070313 EUDAMEDB-08680659070085 EUDAMEDB-08680659070276 EUDAMEDB-08680659070252 EUDAMEDB-08680659070283 EUDAMEDB-08680659070290 EUDAMEDB-08680659070450 EUDAMEDB-08680659070405 EUDAMEDB-08680659070184 EUDAMEDB-08680659070191 EUDAMEDB-08680659070238 EUDAMEDB-08680659070108 EUDAMEDB-08680659070429 EUDAMEDB-08680659070177 EUDAMEDB-08680659070153 EUDAMEDB-08680659070139 EUDAMEDB-08680659070221 EUDAMEDB-08680659070092 EUDAMEDB-08680659070023 EUDAMEDB-08680659070122 EUDAMEDB-08680659070375 EUDAMEDB-08680659070337 EUDAMEDB-08680659070115 EUDAMEDB-08680659070467 EUDAMEDB-08680659070078 EUDAMEDB-08680659070214 EUDAMEDB-08680659070351 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-08680659070313 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Tek-Bal Tibbi̇ Ci̇hazlar San. Ve Ti̇c. Ltd. Şti̇.
- EUDAMED SRN
- TR-MF-000021319
Sources (27)
- EUDAMED bc64e8c2-5818-4e50-91f8-526a5c2bc302 61 fields · synced Aug 3, 2026
- EUDAMED 6223ea30-7943-4685-a2ea-b4fe3de806ca 61 fields · synced May 16, 2026
- EUDAMED 8b0e43a5-22b3-4e2f-a516-33dd191c9fea 61 fields · synced May 16, 2026
- EUDAMED c556d83c-dc08-47a8-a3de-ac1255bdcc07 61 fields · synced May 17, 2026
- EUDAMED a8923567-d4be-4abe-b312-1e206f07195b 61 fields · synced May 17, 2026
- EUDAMED 93d68537-4568-4d54-b613-ab572f44e753 61 fields · synced May 17, 2026
- EUDAMED 28ef2795-ffc5-4532-8443-61eb4381988f 61 fields · synced May 17, 2026
- EUDAMED b2098a7f-f6df-4f91-a383-6f2615d0aa8e 61 fields · synced May 17, 2026
- EUDAMED d4ba1e60-ac46-417c-aa79-86b92532c8e5 61 fields · synced May 17, 2026
- EUDAMED 81f89ed0-8c90-422d-b3c7-e9e6bbad11f8 61 fields · synced May 17, 2026
- EUDAMED 81b1eea5-e2ae-4a9b-ad6e-d0ec7c70033b 61 fields · synced May 17, 2026
- EUDAMED 12c9c334-33af-4e6f-a3c3-e2bf3456b6a2 61 fields · synced May 17, 2026
- EUDAMED 8b113a88-ee7f-4343-9bda-54288e09bbf0 61 fields · synced May 17, 2026
- EUDAMED 0347feea-0c9f-4746-ae72-0110dc98695b 61 fields · synced May 17, 2026
- EUDAMED f519245d-ca2f-4d1e-b81e-e616fdee8810 61 fields · synced May 17, 2026
- EUDAMED 29d89816-5b9e-45b7-a230-f3045088006f 61 fields · synced May 17, 2026
- EUDAMED 80007ac2-846a-4feb-8cf1-60218d6ccbef 61 fields · synced May 18, 2026
- EUDAMED 80d92cca-fbc1-4fb3-ad16-bda51d1b31d4 61 fields · synced May 18, 2026
- EUDAMED 59ffadea-f7a6-4e86-b528-5783b58cfcea 61 fields · synced May 18, 2026
- EUDAMED 67c373de-94f6-44b2-96ea-f9aafa6b77e5 61 fields · synced May 18, 2026
- EUDAMED 1c2b65ee-638e-4f71-9708-a1957332197d 61 fields · synced May 18, 2026
- EUDAMED 7f8753e2-d7d9-4a78-ab3e-014d8b41d7b4 61 fields · synced May 18, 2026
- EUDAMED 97062e7c-b181-461f-af51-1813973734b2 61 fields · synced May 18, 2026
- EUDAMED 32287cab-936e-4cfa-95eb-a975bfb5b96d 61 fields · synced May 18, 2026
- EUDAMED 6c1b716e-afdd-42b1-86ed-e2fbeb882812 61 fields · synced May 18, 2026
- EUDAMED a4c300b0-305e-417a-b748-c84a8af35862 61 fields · synced May 19, 2026
- EUDAMED 90d92b50-4c3e-4bbd-bb1e-36a0b6796867 61 fields · synced May 19, 2026