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Disposable Spinal Fixation Instrument Set
EUDAMEDClass IIa (EU MDR)
Ref SR-TB33-0100-05Ref SR-TB34-0100-11Ref SR-TB33-0100Ref SR-TB34-0100-10-01Ref SR-TB34-0100-05-SRef SR-TB34-0100-04-SRef SR-TB34-0100Ref SR-TB37-0100Ref SR-TB33-0100-03-SRef SR-TB34-0200-01-SRef SR-TB39-0100Ref SR-TB34-0100-03-SRef SR-TB31-0100-01-500-4-SRef SR-TB34-0100-01-500-2-SRef SR-TB34-0200-02-S
Identity
- Trade Name
- Disposable Spinal Fixation Instrument Set EUDAMED
- Device Name
- Disposable Spinal Fixation Instrument Set EUDAMED
- Model / Reference
- SR-TB33-0100-05 EUDAMEDSR-TB34-0100-11 EUDAMEDSR-TB33-0100 EUDAMEDSR-TB34-0100-10-01 EUDAMEDSR-TB34-0100-05-S EUDAMEDSR-TB34-0100-04-S EUDAMEDSR-TB34-0100 EUDAMEDSR-TB37-0100 EUDAMEDSR-TB33-0100-03-S EUDAMEDSR-TB34-0200-01-S EUDAMEDSR-TB39-0100 EUDAMEDSR-TB34-0100-03-S EUDAMEDSR-TB31-0100-01-500-4-S EUDAMEDSR-TB34-0100-01-500-2-S EUDAMEDSR-TB34-0200-02-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949980794650 EUDAMED06949980768279 EUDAMED06949980768231 EUDAMED06949980768255 EUDAMED06949980794483 EUDAMED06949980768262 EUDAMED06949980768248 EUDAMED06949980794636 EUDAMED06949980794520 EUDAMED06949980794544 EUDAMED06949980794612 EUDAMED06949980794506 EUDAMED06949980794476 EUDAMED06949980769177 EUDAMED06949980794568 EUDAMED
- Basic UDI-DI
- B-06949980794650 EUDAMEDB-06949980768279 EUDAMEDB-06949980768231 EUDAMEDB-06949980768255 EUDAMEDB-06949980794483 EUDAMEDB-06949980768262 EUDAMEDB-06949980768248 EUDAMEDB-06949980794636 EUDAMEDB-06949980794520 EUDAMEDB-06949980794544 EUDAMEDB-06949980794612 EUDAMEDB-06949980794506 EUDAMEDB-06949980794476 EUDAMEDB-06949980769177 EUDAMEDB-06949980794568 EUDAMED
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMEDEUDAMED
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
Category: Joint prosthesis implantation kit, single-use
Disposable Spinal Fixation Instrument Set by Shanghai REACH Medical Instrument Co., Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-06949980794650 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shanghai REACH Medical Instrument Co., Ltd
- EUDAMED SRN
- CN-MF-000010269
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (15)
- EUDAMED c5278dff-3736-441e-a0ca-0fb58b41b51f 61 fields · synced Jul 29, 2026
- EUDAMED b1b5fd06-48a8-4a9b-a328-6de3a337eecf 61 fields · synced May 16, 2026
- EUDAMED 676b5108-ee4e-4c65-a652-18ee65653f06 61 fields · synced May 17, 2026
- EUDAMED 87f635c6-a28b-4494-ae1b-206e3cfe90ea 61 fields · synced May 17, 2026
- EUDAMED a083704c-f666-4a0f-873f-060aaee7f68e 61 fields · synced May 17, 2026
- EUDAMED 270cb95a-953d-45fd-b5bd-d7e6472c74ad 61 fields · synced May 18, 2026
- EUDAMED cf94aca6-cd91-404d-93ea-33610a355079 61 fields · synced May 18, 2026
- EUDAMED bc71189d-c5bd-4d48-9006-e7e448899539 61 fields · synced Jun 18, 2026
- EUDAMED 1cb4dc0d-5d25-4fa5-8bc5-c31a5da897dc 61 fields · synced Jun 20, 2026
- EUDAMED c6f6e676-7907-48d1-b030-bd0612818f6f 61 fields · synced Jul 11, 2026
- EUDAMED ea4a643c-97bf-44b8-a80e-fd8463857e0a 61 fields · synced Jul 15, 2026
- EUDAMED 8b223c67-9d77-48d9-a055-9cc4a06a3109 61 fields · synced Jul 16, 2026
- EUDAMED b851ef3d-92df-4aa2-bc83-481a384e662e 61 fields · synced Jul 18, 2026
- EUDAMED f39d672f-9a08-4c72-8e3c-3df383a1ae84 61 fields · synced Jul 19, 2026
- EUDAMED 8fd0e9f2-5fd5-4890-ac8b-5dee8a4ae4e8 61 fields · synced Jul 28, 2026